| Title of guidance | Type and level of guidance | About the guidance | Source |
|---|---|---|---|
| Providing Over-the-Counter Monograph Submissions in Electronic Format | Draft | This guidance provides information on providing electronic submissions to FDA under section 505G of the FD&C Act) (21 U.S.C. 355h) (hereafter referred to as over-the-counter (OTC) monograph submissions). This guidance is intended to assist submitters by describing the electronic OTC monograph submissions requirement in section 505G(j) of the FD&C Act and providing recommendations and other information on how to send such OTC monograph submissions to FDA in electronic format. | FDA |
| Ethical Considerations for Clinical Investigations of Medical Products Involving Children | Draft level 1 guidance | Clinical investigations in children are essential for obtaining data on the safety and effectiveness of drugs, biological products, and medical devices in children and to protect children from the risks associated with exposure to medical products that may be unsafe or ineffective. Children are a vulnerable population who cannot consent for themselves and who therefore are afforded additional safeguards when participating in a clinical investigation. Such safeguards are an essential requirement for the initiation and conduct of pediatric investigations as part of a medical product development program. This guidance describes the FDA’s current thinking regarding ethical considerations for clinical investigations of medical products in children. Clinical investigations involving FDA-regulated products that are not medical products may have similar ethical considerations to those discussed in this guidance but are outside the scope of this guidance. Here, you can view the guidance snapshot and/or listen to the guidance recap podcast. The podcast transcript is available here. You can view other guidance snaphots or listen to podcasts here. | FDA |
| Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry | Final guidance | To help facilitate the availability of naloxone to harm reduction programs, FDA is issuing this guidance to clarify the scope of the public health emergency exclusion and exemption under the DSCSA as they apply to the distribution of FDA-approved naloxone products indicated for the emergency treatment of opioid overdose to harm reduction programs during the opioid public health emergency. This guidance is limited to clarifying the applicability of this public health emergency exclusion and exemption only with respect to the distribution of such naloxone products to: (1) Organizations, referred to in this guidance as “harm reduction programs,” that provide harm reduction services to individuals at risk of experiencing an opioid overdose or those who might respond to an overdose, including providing FDA-approved naloxone products to such individuals (2) Entities/organizations, referred to in this guidance as “harm reduction suppliers,” that distribute FDA-approved naloxone products to harm reduction programs. The guidance does not address the applicability or FDA’s interpretation of the public health emergency exclusion or exemption under the DSCSA as they relate to the distribution of other products during the opioid public health emergency or the distribution of FDA-approved naloxone products among entities other than harm reduction programs or harm reduction suppliers during the opioid public health emergency. Further, the prescription status of drug products and prescription requirements under federal and state law are beyond the scope of this guidance. Therefore, this guidance does not address the prescription-only status of FDA approved naloxone products. | FDA |
| How To Obtain a Covered Product Authorization | Draft guidance | This guidance describes how eligible product developers can obtain a Covered Product Authorization (CPA) from FDA under the law widely known as the CREATES Act (referred ton herein as CREATES or the CREATES Act). The CREATES Act provides a pathway for eligible product developers to obtain access to the product samples they need to fulfill testing and other regulatory requirements to support their applications. As described in further detail below, to make use of this pathway, an eligible product developer seeking to develop a product subject to a Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) must obtain from the Agency a Covered Product Authorization (see 21 U.S.C. 355-2(b)(2)). This guidance replaces the December 2014 draft guidance for industry How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD. The December 2014 guidance has been withdrawn | FDA |
| How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD | Draft guidance | This guidance describes how a prospective abbreviated new drug application (ANDA) applicant may request a letter stating that FDA has determined: (1) that the prospective applicant’s bioequivalence (BE) study protocol contains safety protections comparable to those in the risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) applicable to the reference listed drug (RLD), and (2) that FDA will not consider it a violation of the REMS for the RLD sponsor to provide a sufficient quantity of the RLD to the interested generic firm or its agent to allow the firm to perform the testing necessary to support its ANDA. | FDA |
| Q3D(R2) – Guideline for Elemental Impurities | Final, Level 1 guidance | Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present as impurities (e.g., through interactions with processing equipment or container/closure systems or by being present in components of the drug product). Because elemental impurities do not provide any therapeutic benefit to the patient, their levels in the drug product should be controlled within acceptable limits. There are three parts to this guidance: • The evaluation of the toxicity data for potential elemental impurities • The establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern • The application of a risk-based approach to control elemental impurities in drug products. An applicant is not expected to tighten the limits based on process capability, provided that the elemental impurities in drug products do not exceed the PDEs. The PDEs established in this guidance are considered to be protective of public health for all patient populations. In some cases, lower levels of elemental impurities may be warranted when levels below toxicity thresholds have been shown to have an impact on other quality attributes of the drug product (e.g., element catalyzed degradation of drug substances). In addition, for elements with high PDEs, other limits may have to be considered from a pharmaceutical quality perspective and other guidances should be consulted such as the ICH guidance for industry Q3A(R2) Impurities in New Drug Substances (June 2008) (ICH Q3A(R2). This guidance presents a process to assess and control elemental impurities in the drug product using the principles of risk management as described in the ICH guidance for industry Q9 Quality Risk Management (June 2006) (ICH Q9). This process provides a platform for developing a risk-based control strategy to limit elemental impurities in the drug product. The guidance applies to new finished drug products (as defined in the ICH guidances for industry Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (December 2000 (ICH Q6A) and Q6B Substances: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (August 1999) (ICH Q6B)5 55 and new drug products containing existing drug substances. The drug products containing purified proteins and polypeptides (including proteins and polypeptides produced from recombinant or non-recombinant origins), their derivatives, and products of which they are components (e.g., conjugates) are within the scope of this guidance, as are drug products containing synthetically produced polypeptides, polynucleotides, and oligosaccharides. This guidance does not apply to: • herbal products, radiopharmaceuticals, vaccines, cell metabolites, DNA products, allergenic extracts, cells, whole blood, cellular blood components or blood derivatives including plasma and plasma derivatives, dialysate solutions not intended for systemic circulation, and elements that are intentionally included in the drug product for therapeutic benefit. • to products based on genes (gene therapy), cells (cell therapy) and tissue (tissue engineering). In some regions, these products are known as advanced therapy medicinal products. | FDA |
| Emergency Use Authorization of Medical Products and Related Authorities | Final guidance | This guidance explains FDA’s general recommendations and procedures applicable to the authorization of the emergency use of certain medical products under sections 564, 564A, and 564B of the FD&C Act as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). The provisions in PAHPRA, described in section II of this guidance, include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats such as pandemic influenza. PAHPRA clarifies and enhances FDA’s authority to support emergency preparedness and response and foster the development and availability of medical products for use in these emergencies. These medical products, also referred to as “medical countermeasures” or “MCMs,” include drugs (e.g., antivirals and antidotes), biological products (e.g., vaccines, blood products, and biological therapeutics), and devices (e.g., in vitro diagnostics and personal protective equipment). This guidance finalizes the draft guidance, Emergency Use Authorization of Medical Products and Related Authorities (April 2016) and replaces the following two guidance documents, Emergency Use Authorization of Medical Products (July 2007) and Emergency Use Authorization Questions and Answers (April 2009). | FDA |
| Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products | Draft guidance | This guidance provides recommendations for quantitative labeling of sodium, potassium, and phosphorus present in human prescription and nonprescription (commonly referred to as overthe-counter (OTC)) drugs. This guidance addresses sodium, potassium, and phosphorus when present as constituents of active or inactive drug ingredients3 20 (e.g., sodium as a constituent of the inactive ingredient anhydrous trisodium citrate, phosphorus as a constituent of the inactive ingredient dibasic calcium phosphate, or sodium as a constituent of the active ingredient naproxen sodium). Products within the scope of this guidance’s recommendations are orally ingested products and injectable medications containing an amount of 5 mg or more of sodium, potassium, or elemental phosphorus per maximum single dose. Individuals or entities responsible for drug product labeling are encouraged to engage with FDA for advice on specific cases. | FDA |
| Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products | Final level 1 guidance | To facilitate FDA’s internal tracking of submissions to the Agency that include real-world data (RWD) and real-world evidence (RWE), this guidance encourages sponsors and applicants to identify in their submission cover letters certain uses of RWD/RWE. This guidance does not address FDA’s substantive review of the RWD/RWE submitted as part of the Agency’s standard review process. This guidance applies to submissions for INDs, NDAs and BLAs that contain RWD/RWE intended to support a regulatory decision regarding product safety and/or effectiveness. | FDA |
| Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products | Draft guidance | This guidance provides recommendations on the labeling of human nonprescription drug products for the content and format of the required statement of identity2 20 and the drug product’s strength. The recommendations in this guidance are intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products. | FDA |
| General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products | Draft guidance | This guidance assists sponsors of INDs and applicants of NDAs under section 505 of the FD&C Act, BLAs under section 351(a) of the PHS Act, and supplements to such applications who are planning to conduct clinical studies in pediatric populations. In addition, this guidance assists clinical investigators in the design and planning of, and Institutional Review Boards (IRBs) in the assessment of, clinical studies in pediatric populations. Effectiveness, safety, or dose-finding studies in pediatric populations involve gathering clinical pharmacology information, such as information regarding a product’s pharmacokinetics and pharmacodynamics, to inform dose selection and individualization. This guidance addresses general clinical pharmacology considerations for conducting studies so that the dosing and safety information for drugs in pediatric populations can be sufficiently characterized, leading to well designed trials to evaluate effectiveness. In general, this guidance focuses on the clinical pharmacology information (e.g., exposure response, pharmacokinetics, and pharmacodynamics) that supports findings of effectiveness and safety and helps identify appropriate doses in pediatric populations. This guidance also describes how quantitative approaches (i.e., pharmacometrics) can use disease and exposure-response knowledge from relevant prior clinical studies to help design and evaluate future pediatric studies. This guidance does not describe: (1) the standards for the approval of drugs in the pediatric population; (2) the determination that the course of a disease is the same in adults and pediatric populations; or (3) the clinical pharmacology studies for the development of vaccine therapies, blood products, or other products not regulated by CDER. You can view a snapshot of the guidance here and listen to a guidance recap podcast here. | FDA |
| E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential–Questions and Answers | Final guidance | This question-and-answer (Q&A) document is intended to clarify key issues to facilitate implementing the ICH guidances for industry E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (October 2005) and S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (October 2005).2 This guidance revises ICH E14 Q&As Q12 (5.1) and Q13 (6.1), and adds new ICH S7B Q&As Q17 (1.1) to Q30 (4.2). This guidance finalizes the draft guidance issued in September 2020. | FDA |
| E11A Pediatric Extrapolation | Draft guidance | The purpose of this guideline is to provide recommendations for, and promote international harmonization of, the use of pediatric extrapolation to support the development and authorization of pediatric medicines. Harmonization of the approaches to pediatric extrapolation should reduce the likelihood of substantial differences between regions. Importantly, harmonization should also reduce exposure of pediatric populations to unnecessary clinical trials and facilitate more timely access to pediatric medicines globally. | FDA |
| M12 Drug Interaction Studies | Draft guidance | This guideline provides recommendation to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product. A consistent approach will reduce uncertainty for pharmaceutical industry to meet the requirement of multiple regulatory agencies and lead to more efficient utilization of resources. | FDA |
| Q2(R2) Validation of Analytical Procedures | Draft guidance | This guideline presents a discussion of elements for consideration during the validation of analytical procedures included as part of registration applications submitted within the ICH member regulatory authorities. Q2(R2) provides guidance and recommendations on how to derive and evaluate the various validation tests for each analytical procedure. This guideline serves as a collection of terms, and their definitions. These terms and definitions are meant to bridge the differences that often exist between various compendia and documents of the ICH member regulatory agencies. The document provides an indication of the data which should be presented in a regulatory submission. | FDA |
| Q14 Analytical Procedure Development | Draft guidance | This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products. The systematic approach suggested in ICH Q8 Pharmaceutical Development together with principles of ICH Q9 Quality Risk Management can also be applied to the development and lifecycle management of analytical procedures. When developing an analytical procedure, a minimal (also known as traditional) approach or elements of an enhanced approach can be applied. Furthermore, the guideline describes considerations for the development of multivariate analytical procedures and for real time release testing (RTRT). This guideline is intended to complement ICH Q2 Validation of Analytical Procedures. Submitting knowledge and information related to development of analytical procedures to regulatory agencies may provide additional evidence to demonstrate that the analytical procedure is appropriate for its intended purpose. | FDA |
| Charging for Investigational Drugs Under an IND: Questions and Answers | Draft, Level 1 revised guidance | This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use (21 CFR 312.8), which went into effect on October 13, 2009. Since 2009, FDA has received a number of questions concerning its implementation of the charging regulation. As a result, FDA issued the final guidance for industry Charging for Investigational Drugs Under IND — Questions and Answers (June 2016) providing recommendations in a question-and answer format, addressing the most frequently asked questions. When finalized, this guidance will replace the 2016 guidance. Significant changes to the 2016 version include additional recommendations related to the need for submission of a statement by an independent certified public accountant under certain circumstances, and distribution of the manufacturing, administrative, or monitoring costs from the first year over the expected duration of the expanded access IND or protocol. | FDA |
| FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products | Final guidance | The purpose of this technical specifications document is to assist submitters transmitting electronic individual case safety reports (ICSRs) and ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database. FDA adopted the ICH Implementation Guide (IG) for Electronic Transmission of ICSRs): E2B(R3) Data Elements and Message Specification (ICH ICSR IG)3 in February 2014, and published the guidance for industry E2B(R3) Electronic Transmission of Individual Case Safety Reports: Implementation Guide — Data Elements and Message Specification (E2B(R3) Electronic Transmission of ICSRs IG) and an appendix to the guidance entitled Appendix I (B) to the ICH E2B(R3) ICSRs Implementation Guide — Backwards and Forwards Compatibility. This document describes FDA’s technical approach for submitting ICSRs, for incorporating its regionally controlled terminology and for adding FAERS regional data elements that are not addressed in the E2B(R3) Electronic Transmission of ICSRs IG for the FDA-regulated products stated in the guidance, including the following: · Drug products marketed for human use with approved NDAs or ANDAs · CDER-regulated therapeutic biological products with approved BLAs · Combination products with approved NDAs, ANDAs, or BLAs · Drug and biological products studied under INDs or IND-exempt bioavailability/bioequivalence (BA/BE) studies. | FDA |
| Bioresearch monitoring technical conformance guide | Final guidance | This Guide provides current FDA specifications, recommendations, and general considerations for preparing and submitting: · Clinical Study-Level Information · Subject-Level Data Line Listings by Clinical Site, and a · Summary-Level Clinical Site Dataset that are used by CDER for planning of Bioresearch Monitoring (BIMO) inspections in electronic format for NDAs, BLAs, and NDA or BLA supplemental applications containing clinical data that are regulated by CDER. It also applies when these data and information are submitted under certain INDs applications in advance of a planned NDA, BLA, or supplemental submission. | FDA |
| Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry | Draft guidance | This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND) exempt bioavailability (BA)/bioequivalence (BE) studies through the FDA Adverse Event Reporting System (FAERS) database. An ICSR captures information necessary to support the reporting of an adverse event related to an individual subject that is associated with the use of an FDA-regulated product. The electronic submission of the ICSRs from IND-exempt BA/BE studies is a voluntary option for submission. | FDA |
| General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry | Final guidance | This guidance: · is intended to assist sponsors of INDs and applicants of NDAs, BLAs and supplements to such applications who are planning to conduct clinical studies in neonatal populations. · provides recommendations for neonatal clinical pharmacology studies, whether the studies are conducted pursuant to section 505A of the FD&C Act, section 505B of the FD&C Act, or neither. Effectiveness, safety, or dose-finding studies in neonates involve assessing clinical pharmacology information, such as information regarding a product’s pharmacokinetics (PK) and pharmacodynamics (PD) to inform dose selection and individualization. As such, the general considerations described in this guidance apply to any neonatal studies which incorporate clinical pharmacology assessments. This guidance does not discuss the timing to initiate neonatal studies. Questions regarding the appropriate timing for the initiation of neonatal studies should be discussed with the relevant FDA review division. Here you can view the guidance snapshot and/or listen to a guidance recap podcast. | FDA |
| Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry | Final guidance | This guidance describes CMC post-approval changes related to disposable manufacturing materials that applicants can pursue in drug and biological product manufacturing. This guidance applies to BLA products licensed under section 351(a) or 351(k) of the PHS Act; human drug products marketed as NDAs or ANDAs under section 505(b)(1), 505(b)(2), or 505(j) of the FD&C Act; This guidance applies to all manufacturing establishments, including those that perform functions under contract as defined in the guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements (November 2016). | FDA |
| Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics Guidance for Industry | Draft Level 1 guidance | This guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of a regulatory submission to FDA to provide information on their use of RWE in a simple, uniform format. FDA will use this information for internal tracking purposes only. This guidance applies to submissions for INDs, NDAs and BLAs that contain RWE used to support regulatory decisions regarding safety and/or effectiveness. | FDA |
| Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices | Final guidance Medical Devices | This guidance: · describes FDA’s policies with regard to enforcement of these requirements for class I and unclassified devices, including the Agency’s compliance policy regarding GUDID submission requirements under CFR 830.300 for certain class I devices considered consumer health products. In addition, the guidance describes how a labeler of a class I device can determine whether its device is within the scope of that compliance policy. · reiterates FDA’s direct mark compliance policy for class III, LS/LS, and class II devices that are non-sterile, that are manufactured and labeled prior to their applicable direct mark compliance date, and that remain in inventory, as well as for class I and unclassified devices that are not LS/LS devices, that are non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory. | FDA |
| Real-Time Oncology Review (RTOR) | Draft guidance | The purpose of this guidance is to provide recommendations to applicants on the process for submission of selected NDA and BLA with oncology indications for review under the Real-Time Oncology Review (RTOR). This guidance does not address FDA’s expedited programs such as the Fast Track Designation, Breakthrough Therapy Designation, or Priority Review Designation. Additional information on these expedited programs can be found in the Guidance for Industry: Expedited Programs for Serious Conditions –Drugs and Biologics. The FDA Oncology Center of Excellence (OCE), in collaboration with the Office of Oncologic Diseases (OOD), commenced the RTOR program in February 2018 to facilitate earlier submission of top-line results (i.e., efficacy and safety results from clinical studies before the study report is completed) and datasets, after database lock, to support an earlier start to the FDA application review. Initially, only supplemental oncology drug applications (to add new indications, dosing regimens, or other clinical information to the prescribing information) were reviewed under RTOR. Later the program was expanded to include select original oncology NDAs for new molecular entities (NMEs) submitted under section 505(b) of the FD&C Act and original oncology BLAs submitted under section 351(a) of the Public Health Service Act. | FDA |
| Orange Book Questions and Answers Guidance for Industry | Final guidance | This guidance is intended to assist prospective and current drug product applicants and approved application holders in using the Orange Book. The guidance provides answers to commonly asked questions FDA has received from these interested parties regarding the Orange Book and covers topics such as the content and format of the Orange Book, petitioned ANDAs, the movement of drug products between the Active and Discontinued sections in the Orange Book, and patent listings. | FDA |
| Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry | Final, Level 1 guidance | This guidance: · provides information and recommendations regarding potential courses of action for an abbreviated new drug application (ANDA) applicant after the issuance of a complete response letter (CRL) as well as the actions that the FDA may take if the applicant fails to respond to a CRL. · also identifies information that an applicant may submit in its request for an extension to respond to a CRL as well as a non-exhaustive list of factors that the FDA generally intends to consider in determining whether such a request is reasonable. In this guidance, which finalizes the draft published in September 2020, the FDA added an appendix that provides examples of factors that the agency could consider as the basis for concluding that an applicant’s request for an extension of time to respond to a CRL is reasonable. | FDA |
| Conducting Remote Regulatory Assessments Questions and Answers | Draft guidance | In response to the Coronavirus COVID-19 pandemic, FDA adapted its operations for field activities to provide oversight of regulated industry while mitigating the spread of COVID-19. One set of tools used during the pandemic for oversight of FDA-regulated products has been remote regulatory assessments (RRAs), as further described in this guidance. The term “RRA” is used to describe a category of activities for which FDA may use different terminologies, but that are all considered to be types of RRAs, including “remote interactive evaluations, and “remote record reviews.” Such activities, along with others identified in this guidance, are considered RRAs for purposes of this guidance. In the presence of travel restrictions during the COVID-19 pandemic, FDA utilized certain types of RRAs to assess establishments and their compliance with applicable FDA requirements. Based on this experience, FDA has noted the value of RRAs and concluded that they should be used for certain scenarios outside the current pandemic and for all types of FDA-regulated products. FDA has developed this guidance to provide answers to frequently asked questions related to RRAs. This guidance is intended to help enhance industry’s understanding of RRAs, thereby facilitating FDA’s process for conducting remote assessments. | FDA |
| Evaluation of Therapeutic Equivalence | Draft guidance | This guidance explains FDA’s therapeutic equivalence evaluations, including the assignment of therapeutic equivalence codes (or TE codes). As defined in 21 CFR 314.3(b), therapeutic equivalents are approved drug products that FDA has determined are pharmaceutical equivalents for which bioequivalence has been demonstrated, and that can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. FDA’s therapeutic equivalence evaluations are listed for multisource prescription drug products approved under section 505 of the &C Act in the active section of the Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the Orange Book). As FDA explained when it first proposed to make available a list of all approved drug products, together with therapeutic evaluations of listed products that are available from more than one manufacturer, therapeutic equivalence evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. For example, the Orange Book can assist in the establishment of formularies that States and other entities may use in determining when drug products may be substituted for one another. If lower-cost, therapeutically equivalent drug products are available, American consumers are more likely to receive savings on these products. Therapeutic equivalence evaluations are a scientific judgment based upon evidence, while generic substitution may involve social and economic policy administered by the states, e.g., reducing the cost of drugs to consumers. These evaluations do not constitute determinations that any product is in violation of the FD&C Act or that any product is preferable to any other. | FDA |
| Human Prescription Drug and Biological Products–Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers–“Dose Banding” | Draft guidance | This guidance provides recommendations to assist applicants in incorporating information into proposed human prescription drug labeling when: · Dosing for the drug product is based on weight or body surface area (BSA). · The drug product is available in a range of strengths in ready-to-use containers. · The entire drug content of the ready-to-use container(s) is intended to be administered to a patient. This practice is referred to as dose banding. This guidance: · applies to proposed labeling in a new drug application (NDA) submitted under section 505(b) of the FD&C Act; a biologics license application (BLA) submitted under section 351(a) of the PHS Act; or a supplement to one of these approved applications. · does not apply to ANDAs, which are generally required to have the same labeling as the reference listed drug. · also does not apply to 351(k) BLAs; the labeling of biosimilar and interchangeable products generally incorporates relevant data and information from the reference product labeling with certain modifications | FDA |
| Investigational New Drug Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations Guidance for Sponsor-Investigators | Draft, Level 1 guidance | This guidance is intended for sponsor-investigators (hereafter referred to as sponsors) developing individualized investigational antisense oligonucleotide (ASO) drug products for a severely debilitating or life-threatening (SDLT) genetic disease. Most often, individuals with such diseases will have no alternative treatment options, and their diseases will be rapidly progressing, resulting in early death and/or devastating or irreversible morbidity within a short time frame without treatment. In these situations, drug development targeted to a larger number of patients with the same disease is not anticipated because of the specificity of the mechanism of action of the ASO combined with the rarity of the treatment-amenable patient population. The gene variant or variants that are targeted by the ASO drug product should be unique to the trial participant(s) and generally only reported in a small number of patients (typically 1 to 2) in the disease population. If more than a few patients may be candidates for targeted treatment with the ASO drug product, then the ASO is no longer considered individualized, and the sponsor should discuss a drug development plan of the investigational ASO drug product for a larger patient population with the relevant review division. | FDA |
| Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format | Final guidance | This guidance provides recommendations for developing the content and format of a patient Instructions for Use (IFU) document for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under an NDA or a BLA. The IFU is written for patients (or their caregivers) who use drug products that have complicated or detailed patient-use instructions. The recommendations in this guidance are: · intended to help ensure that patients receive clear and concise information that is easily understood for the safe and effective use of such products. · also intended to help provide consistency to the content and format of IFU documents. | FDA |
| Identifying Trading Partners Under the Drug Supply Chain Security Act | Draft guidance | The FDA is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA).This guidance revises the Agency’s draft guidance for industry Identifying Trading Partners Under the DSCSA August 2017 to address the status of some entities as trading partners (e.g., private-label distributors, salvagers, and returns processors and reverse logistics providers), provide clarification on certain drug distribution scenarios, and address the interpretation of section 582(a)(7) of the FD&C Act, which discusses third-party logistics providers (3PL) licensure status prior to the effective date of the forthcoming regulations establishing licensure standards. The DSCSA establishes product tracing requirements for certain trading partners in the drug supply chain, including manufacturers, repackagers, wholesale distributors, and dispensers. The DSCSA also requires that trading partners of manufacturers, wholesale distributors, dispensers, and repackagers must meet the applicable requirements for being “authorized trading partners.” Additionally, the DSCSA requires FDA to issue regulations that establish Federal standards for the licensing of wholesale drug distributors (WDDs) and 3PLs. The Agency is currently drafting these regulations. This guidance, when finalized, will explain FDA’s current thinking on how certain DSCSA requirements apply to entities that are considered trading partners in the drug supply chain. This guidance is intended to: (1) assist industry and State and local governments in understanding the applicability of DSCSA requirements to the various types of entities that take part in the distribution of prescription drugs in the United States; and (2) help clarify for industry whether they are engaged in activities that require licensure and annual reporting, as well as other requirements related to being an authorized trading partner in the drug supply chain. The guidance does not address all requirements described in the DSCSA but is limited to describing the activities that would determine what type of trading partner an entity may be and the applicable requirements under the DSCSA. | FDA |
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