| Title of guidance | Type and level of guidance | About the guidance | Source |
|---|---|---|---|
| Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry | Draft guidance | This guidance: • is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling following revisions to the approved labeling of a reference listed drug (RLD). • provides recommendations on identifying RLD labeling updates and submitting ANDA amendments or supplements to update generic drug labeling. • revises the guidance for industry Revising ANDA Labeling Following Revision of the RLD Labeling (April 2000). After it has been finalized, this guidance will replace the April 2000 guidance. Significant changes from the 2000 version include updates to outdated details about how to obtain information on changes to RLD labeling and how to submit revised ANDA labeling to FDA. | FDA |
| Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions | Final guidance | The purpose of this document is to state that the FDA, at this time and based its our current understanding of the risks, does not intend to enforce certain regulatory requirements as they currently apply to certain entities and/or activities. The applicable requirements are established in the FDAregulations entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (21 CFR Part 507); “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (21 CFR Part 117); “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (21 CFR Part 1, Subpart L (FSVP)); “Mitigation Strategies to Protect Food Against Intentional Adulteration” (21 CFR Part 121); and “Standards for Growing, Harvesting,Packing, or Holding of Produce for Human Consumption” (21 CFR Part 112). • Section II of this document describes certain enforcement discretion policies that were issued previously and are relevant to the enforcement policies discussed in sections III.B and III.C. • Section III describes new or extended enforcement discretion policies. • Section III.A describes FDA’s extension enforcement discretion in certain circumstances when a receiving facility that is a contract manufacturer/processor not in compliance with certain supply-chain program requirements for food manufactured for a brand owner. • Section III.B describes that the FDA does not intend to enforce requirements of the Intentional Adulteration regulation for facilities under the preexisting farm-activity related enforcement policy. • Section III.B also announces that FDA does not intend to enforce the Intentional Adulteration regulation’s requirement for reanalysis in certain circumstances—for example, when there is a single failure that is addressed through implementation of corrective action procedures. • Section III.C describes that FDA does not intend to enforce the supplier approval and verification requirements in part 117, part 507, and the FSVP regulation with regard to supplier compliance with requirements that are already associated with an enforcement discretion policy. | FDA |
| Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs | Draft, Level 1 revised guidance | FDA is issuing this guidance to describe FDA’s interpretation of the requirements of section 582 of the FD&C Act regarding verification systems. This guidance provides recommendations for a robust verification system for the determination, quarantine, and investigation of suspect products, as well as the quarantine, notification, and disposition of illegitimate products. The guidance also addresses the manner in which FDA recommends that trading partners submit cleared product notifications. Finally, this guidance addresses the statutory requirements for verification, including verification of saleable returns, at the package level for product identifiers on packages and homogenous cases intended to be introduced in a transaction into commerce. This guidance revises the draft guidance for industry Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, issued in October 2018, including to address comments received from stakeholders | FDA |
| Inclusion of Older Adults in Cancer Clinical Trials | Final guidanc e | This guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer. For the purpose of this guidance, older adults are those 65 years of age and older. Specifically, this guidance includes recommendations for including an adequate representation of older adults in cancer clinical trials to better enable evaluation of the benefit-risk profile of cancer drugs in this population. Most cancer trials do not have an upper age limit for exclusion; however, adults 75 years of age and older are underrepresented in cancer clinical trials. The guidance emphasizes the particular importance of including adults 75 years of age and older in cancer clinical trials. This guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of cancer clinical trials. Enrolling an adequate representation of the range of patients in a clinical trial that may be exposed to a drug after approval is important. It provides the ability to understand the drug’s benefit-risk profile across the patient population likely to use the drug in clinical practice (e.g., to identify whether there are differences in the benefits and/or risks of the drug in different populations). Including information in the labeling describing use in older adults may help promote the safe and effective use of these products in older adults and better inform treatment decisions in clinical practice. | FDA |
| Pre-Launch Activities Importation Requests (PLAIR) | Final, Level 1 guidance | This guidance finalizes the July 2013 draft guidance Pre-Launch Activities Importation Requests (PLAIR), which describes the FDA’s policy regarding requests for the importation of unapproved finished dosage form drug products by an applicant preparing the product for U.S. market launch based on anticipated approval of a pending NDA or ANDA. This guidance also applies to unapproved BLAs regulated by the Center for Drug Evaluation and Research (CDER), and unapproved combination products assigned to CDER (21 CFR part 3) for which NDA, ANDA, or BLA approval is anticipated. Moreover, this guidance describes the procedures for making requests for importation of unapproved finished dosage form drug products before final approval of the application and the factors that FDA will consider in granting such requests. | FDA |
| Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry | Final, Level 1 guidance | The purpose of this guidance is to provide advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical development of oncology drugs, including biological products, through multiple expansion cohort trial designs. These are trial designs that employ multiple, concurrently accruing subject cohorts, where individual cohorts assess different aspects of the safety, pharmacokinetics, and antitumor activity of the drug product. This guidance: • provides FDA’s current thinking regarding (1) characteristics of drug products best suited for consideration for development under a multiple expansion cohort trial; (2) information to include in investigational new drug applications (INDs) to support the use of individual cohorts; (3) when to interact with FDA on planning and conduct of multiple expansion cohort trials; and (4) safeguards to protect subjects enrolled in FIH expansion cohort trials. • does not address all issues relating to clinical trial design, statistical analysis, or the biomarker development process. Those topics are addressed in other guidances including the International Council for Harmonisation (ICH) guidances for industry E9 Statistical Principles for Clinical Trials (September 1998) and E10 Choice of Control Group and Related Issues in Clinical Trials (May 2001) as well as the guidance for industry and FDA staff In Vitro Companion Diagnostic Devices (August 2014). | FDA |
| Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry | Final, Level 1 guidance | This guidance: • provides recommendations to sponsors of drugs or biologics for the treatment of cancer regarding the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. In general, the recommended phase 2 dose (RP2D) should have been established for an investigational drug or drugs evaluated in a master protocol. • is intended to serve as advice and a focus for continued discussions among FDA, pharmaceutical sponsors, the academic community, and the public • describes aspects of master protocol designs and trial conduct and related considerations, such as biomarker codevelopment and statistical analysis considerations, and provides recommendations on the information that sponsors should submit to FDA and on how sponsors can interact with FDA to facilitate efficient review • does not cover first-in-human or early stage clinical trials using expansion cohorts to expedite drug development. FDA addresses that topic in the draft guidance for industry | FDA |
| Container Closure Systems for Packaging Human Drugs and Biologics — Questions and Answers | Final | This document provides questions and answers relating to the guidance on Container Closure Systems for Packaging Human Drugs and Biologics (the guidance).2 The questions are based onthose posed to CDER by applicants. | FDA |
| Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders | Final, Level 1 guidance | This guidance (Guidance 2) is the second in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product3 development and regulatory decision-making. The topics that each guidance document addresses are described below. • Methods to collect patient experience data that are accurate and representative of the intended patient population (Guidance 1) • Approaches to identifying what is most important to patients with respect to their experience as it relates to burden of disease/condition and burden of treatment (Guidance 2) • Approaches to selecting, modifying, developing, and validating clinical outcome assessments to measure outcomes of importance to patients in clinical trials (Guidance 3) • Methods, standards, and technologies for collecting and analyzing clinical outcome assessment (COA) data for regulatory decision-making (Guidance 4), including selecting the COA-based endpoint and determining clinically meaningful change in that endpoint About Guidance 2 This guidance will discuss methods for eliciting information from individuals identified in Guidance 1. It will discuss best practices in conducting qualitative research and reference-related resources ; however, it should not be viewed as providing detailed instructions on how to use particular methods or as a substitute for engaging subject matter experts when undertaking the work described. The methods described in this document can be used to elicit what is important to patients, which may in turn help inform understanding of disease/condition and clinical trial design. It may also help the generation and use of patient experience data, including clinical outcome assessments and patient preference information, to inform benefit-risk assessment. | FDA |
| FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making | FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making. This series of guidance documents is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can better inform medical product development and regulatory decision making. These guidances are part of FDA’s PFDD efforts in accordance with the 21st Century Cures Act and The Food and Drug Administration Reauthorization Act of 2017 Title I. Guidance 1: Collecting Comprehensive and Representative Input Guidance 2: Methods to Identify What is Important to Patients Guidance 3: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments Guidance 4: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making | FDA | |
| eCTD Technical Conformance Guidance | Final guidance | This Document is incorporated by reference into the following Guidance Document(s): Guidance for Industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications This eCTD Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic Common Technical Document (eCTD)-based electronic submissions to the CDER or the CBER. The Guide supplements the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (eCTD Guidance). The eCTD Guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act with respect to electronic submissions for certain INDs; NDAs;ANDAs; certain BLAs; and master files submitted to CDER or CBER. These submissions may apply to combination products with CDER or CBER as the lead center. | FDA |
| Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials | Draft guidance | The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidal ideation and behavior in clinical trials of drug and biological products. The focus of this guidance is on clinical trials conducted under investigational new drug applications, or trials that are intended for submission in a new drug application or a biologics license application. Specifically, this guidance addresses the FDA’s current thinking regarding the importance of assessment of suicidal ideation and behavior in psychiatric and nonpsychiatric drug trials falling under the authority of the FDA, and the general principles for how best to accomplish this assessment during drug development. This guidance is not intended to give advice on how best to screen patients for entry into clinical trials, even though instruments used for assessing patients during the conduct of trials can also be used for screening patients. Making decisions about which patients to enter into a particular trial is a separate matter that is determined largely by the questions that the trial is intended to address. The principles discussed in this guidance for the prospective assessment of suicidal ideation and behavior involve actively querying patients about the occurrence of suicidal thinking and behavior, rather than relying on patients to report such occurrences spontaneously, followed by retrospective classification of events into appropriate categories. This guidance offers advice about criteria that should be met for a suicidal ideation and behavior assessment instrument that can be used to conduct such prospective assessments. This guidance is intended to serve as a focus for continued discussions among the FDA, pharmaceutical sponsors, the academic community, and the public.3 This guidance does not address the complex analytic issues involved in the analysis of the suicidal ideation and behavior data that will be derived from prospective assessments of suicidal ideation and behavior; these issues will be addressed in a separate guidance. | FDA |
| Product-specific guidances (PSGs) | On Feb. 17, the FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA. The 43 PSGs include 13 for complex products and new PSGs for medications to treat diseases such as COVID-19, spinal muscular atrophy, non-small cell lung cancer and prostate cancer. | ||
| Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry | Draft, Level 1 guidance | This guidance provides recommendations to assist industry and other parties involved in the development of antibody-drug conjugates (ADCs) with a cytotoxic small molecule drug or payload. Specifically, this guidance addresses the FDA’s current thinking regarding clinical pharmacology considerations and recommendations for ADC development programs, including bioanalytical methods, dosing strategies, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interactions (DDIs). This guidance specifically outlines clinical pharmacology considerations of ADC development programs and references other relevant guidances when appropriate. ADCs are subject to all pertinent laws and regulations for biological products, including those governing product development, testing, and approval as outlined in section of the PHS Act. Given that ADCs include a small-molecule drug, there are other guidances that are applicable to ADCs that would not necessarily apply to other biological products. Of note, this guidance does not focus on the development of any particular ADC, and questions about regulatory requirements and development programs for a particular ADC should be addressed to the appropriate FDA review division. | FDA |
| FDA’s guidance on uniform national policy (Section 585 of the FD&C Act) | Final guidance | The FDA is issuing these questions and answers to assist industry and State and local governments in understanding the effects of section 585 (Uniform National Policy) of the FD&C Act, added by Title II of the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013, on drug product tracing. Title II, which is also referred to as the Drug Supply Chain Security Act (DSCSA), establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution supply chain and requires trading partners to pass, receive, and maintain certain product and distribution information. Section 585 requires there be a uniform national policy, preempting States from establishing or continuing in effect certain standards and requirements. FDA is issuing this guidance to: (1) help industry and States understand the law as it is currently in effect; and (2) clarify the effect of section 585(a) on any regulation of drug product tracing by States. | FDA |
| Population Pharmacokinetics | Final Level 1 guidance | This guidance is intended to assist sponsors and applicants of NDAs, BLAs, ANDAs, and IND applications in the application of population pharmacokinetic (PK) analysis. Population PK analysis is frequently used to guide drug development and inform recommendations on therapeutic individualization (e.g., through tailored dosing). Adequate population PK data collection and analyses submitted in marketing applications have in some cases alleviated the need for postmarketing requirements or postmarketing commitments. This guidance: -includes common applications of population PK analysis to inform drug development and drug use. This list of applications is not meant to be comprehensive, but rather provides illustrative examples. -also includes the FDA’s current thinking on the data and model submissions to support regulatory decisions, recommendations on how to incorporate information from population PK analyses in labeling, and the general expectations regarding the format and content for population PK reports submitted to the Agency. You can view a snapshot of the guidance here. You can also listn to a podccast recap of the guidance here. The transcript of the podcast recap is available here. | FDA |
| Assessment of Pressor Effects of Drugs Guidance for Industry | Draft Level 1 revised guidance | The recommendations in the guidance are generally applicable to new drugs with systemic bioavailability and to approved drugs for a new indication/population with a higher cardiovascular risk or when a new dosing regimen results in significantly higher or more prolonged exposure. This guidance revises the draft guidance for industry Assessment of Pressor Effects of Drugs issued in May 2018. This revision provides greater detail about study design, including specific statistical powering recommendations that were not included in the original document. Furthermore, this revision provides recommendations on how to incorporate information about increased blood pressure in the prescribing information of drug product labeling. | FDA |
| Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling–Content and Format | Draft, level 1 guidance | The purpose of this guidance is to assist applicants with incorporating immunogenicity information into the labeling of human prescription biological products, specifically therapeutic protein products, and of select drug products that have immunogenicity assessments. This guidance provides recommendations to help ensure that clinically relevant immunogenicity information is included in and distributed appropriately across sections and subsections of product labeling, in accordance with regulatory requirements for the content and format of human prescription drug and biological product labeling. The goal of appropriate inclusion and distribution of clinically relevant immunogenicity information in the labeling is to enable health care practitioners to easily access, understand, and use this information to inform prescribing decisions and patient management, and to help enable safe and effective use of applicable products. When finalized, this guidance will supersede the immunogenicity labeling-specific recommendations in the guidance for industry Labeling for Biosimilar Products (July 2018) and the guidance for industry Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (December 2016) This guidance does not apply to products intended to induce a specific immune response to prevent or treat a disease or condition (such as vaccines and allergenic products). This guidance does not address scientific aspects of immunogenicity assessments, including the following: • Development and validation of assays for anti-drug antibody detection• Immunogenicity risk assessment • Design and conduct of immunogenicity studies • Scientific and clinical analysis of immunogenicity data (e.g., criteria for determining whether observed anti-drug antibodies affect the pharmacokinetics, pharmacodynamics, effectiveness, or safety of a product) | FDA |
| Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications | Draft guidance | This guidance provides recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical delivery systems (collectively referred to as TDS). Adhesion performance is defined in this guidance as whether the TDS fully adheres to the subject in the applied location for the duration of use of the TDS. Adhesion performance can affect both safety and effectiveness of TDS products because adhesion failures can result in reduced effectiveness caused by suboptimal dosing or potentially increased exposure when a new TDS needs to be applied sooner than the scheduled dose. Additionally, partial or full detachment of a TDS from a patient’s skin may result in unintentional exposure of the active pharmaceutical ingredient to a partner, child, or other individual, potentially exposing them to the drug’s toxicity. Adhesion performance may also inform the Dosage and Administration section of labeling. The recommendations in this guidance relate to studies to be submitted in support of a new drug application (NDA) or supplemental new drug application (sNDA) for human prescription and nonprescription drug products under Section 505 of the FD&C Act and 21 CFR Part 314. Because biological products are often more complex and of a higher molecular weight, it is likely that these products would not be absorbed across the skin, requiring a different approach for administration, so they are outside the scope of this guidance. | FDA |
| Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies | Draft guidance | This guidance: -provides recommendations to help sponsors comply with the expedited safety reporting requirements for human drug and biological products that are being investigated (1) under an investigational new drug application (IND) (21 CFR 312.32) or (2) as part of a 21 bioavailability (BA) or bioequivalence (BE) study that is exempt from the IND requirements (21 22 CFR 312.64(b) and 320.31(d)(3)). -defines terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides information on other safety reporting issues raised by sponsors. -to facilitate appropriate IND safety reporting practices, also provides recommendations related to the two IND safety reporting provisions (21 CFR 312.32(c)(1)(i)(C) 30 and 312.32(c)(1)(iv)) that require assessment of aggregate data. -merges content from the final guidance for industry and investigators Safety Reporting Requirements for INDs and BA/BE Studies (December 2012) (the 2012 final guidance) and from the draft guidance for industry Safety Assessment for IND Safety Reporting (December 2015) (the 2015 draft guidance). -includes revised recommendations initially described in the 2015 draft guidance on the following topics: (1) planned unblinding of safety data and implications for trial integrity; (2) increased flexibility regarding the party reviewing aggregate safety information for IND safety reporting purposes; (3) clarification regarding the scope and methodology of aggregate analyses; and (4) clarification regarding the plan for safety surveillance, including what elements should be included in the plan. -does not incorporate content on investigator reporting (21 CFR 312.64(b)) from the 2012 final guidance. -addresses reporting of serious adverse events (SAEs) in the setting of a clinical investigation conducted under an IND. Drugs used in such clinical investigations may be unapproved drugs or those that are already marketed or approved in the United States. For drugs already marketed or approved, additional reporting requirements for safety information from clinical studies are specified by the relevant postmarketing safety reporting requirements (e.g., under 21 CFR 314.80, 600.80, or 606.170 or under section 760 of the FD&C Act. This guidance does not address those obligations. | FDA |
| Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations | Draft guidance | This guidance provides recommendations regarding in vitro testing of oral drug products, other than solutions, administered via enteral feeding tube (hereinafter enteral tube). These products represent a wide range of oral dosage forms including, but not limited to, granules, pellets, powders, suspensions, capsules, and tablets. The recommendations for in vitro testing apply to products that are subject to the following and submitted under section 505 of the FD&C Act and 21 CFR parts 312 and 314: • New drug applications (NDAs) (original or supplemental) where applicants are seeking and/or revising enteral tube administration instructions and related information in labeling • Abbreviated new drug applications (ANDAs) where the reference listed drug (RLD) 31 contains enteral tube administration instructions and related information in labeling • Investigational new drug applications where the investigational drug product is administered or planned for administration via enteral tube Specifically, the guidance covers: • In vitro testing recommendations to ensure oral drug product quality and, as applicable, bioequivalence to the RLD when evaluating a drug product’s suitability for administration via enteral tube • Appropriate content and format for submission of in vitro testing results regarding administration via enteral tube • Recommendations on how to incorporate information about administration via enteral tube in drug product labeling when supported by in vitro testing results | FDA |
| Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products | This guidance: -represents FDA’s current thinking on adjusting for covariates in the statistical analysis of randomized clinical trials in drug development programs. -provides recommendations for the use of covariates in the analysis of randomized, parallel group clinical trials that are applicable to both superiority trials and noninferiority trials. The main focus of the guidance is on the use of prognostic baseline factors to improve precision for estimating treatment effects rather than the use of predictive biomarkers to identify groups more likely to benefit from treatment. -does not address use of covariates to control for confounding variables in non-randomized trials or the use of covariate adjustment for analyzing longitudinal repeated measures data. -revises the draft guidance for industry Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes issued in April 2019. This revision provides more detailed recommendations for the use of linear models for covariate adjustment and also includes recommendations for covariate adjustment using nonlinear models. | FDA | |
| Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention Guidance for Industry | Draft guidance | The purpose of this guidance is to help sponsors in the clinical development of drugs for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adults. Specifically, this guidance addresses FDA’s current recommendations on clinical trials for drugs being developed under Section 505 of the FD&C Act and 21 CFR Parts 312 and 314 for the prevention of CINV and considerations for eligibility criteria, trial design features, efficacy evaluations, and clinical outcome assessments. This guidance does not address the development of drugs for the treatment of CINV or the prevention or treatment of nausea and vomiting unrelated to the administration of chemotherapeutic agents | FDA |
| Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1) | Draft guidance | This guidance: -is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biological products. -applies to clinical investigations conducted under 21 CFR part 312 (investigational new drug application (IND) regulations) and describes how to complete the Statement of Investigator (Form FDA 1572). -when finalized, partially revises the Form FDA 1572 FAQ Guidance and answers additional questions received by FDA. | FDA |
| Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry | Draft guidance | This draft, revised guidance: – describes FDA’s statutory authority to require certain postmarketing studies and clinical trials under section 505(o)(3) of the FD&C Act (i.e., postmarketing requirements (PMRs) and provides an overview of the types and purposes of such studies and clinical trials. – also describes those types of postmarketing studies and clinical trials that are agreed upon (i.e., postmarketing commitments (PMCs))6 between FDA and the applicant. – is a revision of the guidance for industry Postmarketing Studies and Clinical 32 Trials—Implementation of Section 505(o)(3) of the FD&C Act published in April 2011. – provides information on implementation of sections 505(o)(3)(D)(i) and (ii) of the FD&C Act. – also reflects certain provisions enacted under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act as they relate to postmarketing studies and clinical trials. – does not distinguish between prescription drugs with active ingredients that are controlled substances and other prescription drugs because, at this time, the Agency does not intend to treat controlled substances differently than other prescription drugs under 505(o). – will replace the April 2011 guidance once finalised – does not apply to nonprescription drugs approved under a new drug application or to generic drugs approved under section 505(j) of the FD&C Act. | FDA |
| Principles of Premarket Pathways for Combination Products | Final guidance | This guidance presents the current thinking of FDA on principles for premarket review of combination products. This guidance offers general, high-level information regarding what combination products are, coordination within FDA and interaction between FDA and sponsors regarding combination product regulation, and how combination products are reviewed by FDA before they are marketed. The remainder of this guidance focuses on how to determine which type of premarket submissions may be appropriate for combination products. The Agency has published guidance on premarket review issues relevant to specific categories of combination products and will continue to use such guidance as needed to provide more detailed information on specific premarket considerations and specific types of combination products. | FDA |
| Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry | Final, level 1 guidance | This guidance explains how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the assessment of an original abbreviated new drug application (ANDA) under section 505(j) of the FD&C Act, as contemplated in the Generic Drug User Fee Amendments of 2017 (GDUFA II). This guidance does not apply to an amendment made in response to a complete response letter (CRL), a supplement, or an amendment to a supplement. More information here. | FDA |
| Good ANDA Submission Practices Guidance for Industry | Final, Level 1 guidance | This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs). It highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA. It also makes recommendations to applicants on how to avoid these deficiencies with the goal of minimizing the number of review cycles necessary for approval. More information here. | FDA |
| Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry | Draft, Level 1 guidance | This guidance is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling following revisions to the approved labeling of a reference listed drug (RLD). This guidance: -provides recommendations on identifying RLD labeling updates and submitting ANDA amendments or supplements to update generic drug labeling. -revises the guidance for industry Revising ANDA Labeling Following Revision of the RLD Labeling (April 2000). -after it has been finalized, will replace the April 2000 guidance. Significant changes from the 2000 version include updates to outdated details about how to obtain information on changes to RLD labeling and how to submit revised ANDA labeling to FDA. More information here. | FDA |
| Collecting and Providing 702(b) Portions of FDA Official Samples | Draft | This draft guidance is intended to assist FDA staff and industry with issues and questions related to the requirements for FDA to collect and provide portions of official samples under section 702(b) of the D&C Act and its implementing regulation in Title 21 Code of Federal Regulations (CFR) section 2.10 (21 CFR 2.10). Section 702 of the FD&C Act authorizes FDA to conduct examinations and investigations and to collect samples. FDA uses the term 702(b) portion to refer to the part of FDA’s official sample of a food, drug, or cosmetic that FDA is required to provide to the owner, upon request under section 702(b) of the FD&C Act. FDA will collect and provide a 702(b) portion in accordance with 702(b) of the FD&C Act and its implementing regulation in 21 CFR 2.10. | FDA |
| Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act | Draft guidance (Medical devices) | The FDA is issuing this guidance to: – implement section 506J of the FD&C Act as added by section 3121 of the CARES Act, as it relates to notifying FDA of a permanent discontinuance or interruption in the manufacturing of a device that is likely to lead to a meaningful disruption in the supply of that device during or in advance of a public health emergency. -assist stakeholders in the Agency’s implementation of section 506J of the FD&C Act outside of the COVID-19 public health emergency, and will serve as the baseline for information about notifications under section 506J of the FD&C Act during or in advance of any public health emergency. This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages of such devices. This guidance also recommends that manufacturers voluntarily provide additional details to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during or in advance of a public health emergency. | FDA |
| Principles of Premarket Pathways for Combination Products | Final guidance | This guidance presents the current thinking of FDA on principles for premarket review of combination products. This guidance offers general, high-level information regarding what combination products are, coordination within FDA and interaction between FDA and sponsors regarding combination product regulation, and how combination products are reviewed by FDA before they are marketed. The remainder of this guidance focuses on how to determine which type of premarket submissions may be appropriate for combination products. The Agency has published guidance on premarket review issues relevant to specific categories of combination products and will continue to use such guidance as needed to provide more detailed information on specific premarket considerations and specific types of combination products. | FDA |
| Providing Regulatory Submissions in Electronic Format — Standardized Study Data | Final, Level 1 guidance | This guidance and the technical specifications documents it incorporates by reference describe the requirements for an electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the FD&C Act. In accordance with section 745A(a), following the issuance of a final guidance on this topic, study data contained in the submission types identified in this guidance must be submitted electronically (at least 24 months after the issuance of a final guidance document) in a format that FDA can process, review, and archive. This guidance implements the electronic submission requirements of section 745A(a) of the 21 FD&C Act for study data contained in NDAs, ANDAs, BLAs, and INDs, to CDER or CBER by specifying the format for electronic submissions. Submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review, and archive will not be filed or received, unless exempt from the electronic submission requirements or if FDA has granted a waiver. | FDA |
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