FDA issued guidance for industry – September 2021

Last updated: 30 September 2021

Title of guidanceType and level of guidanceAbout the guidanceSource
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and AnswersThis guidance provides information for firms about how FDA evaluates firms’ medical product communications that fall within the scope of FDA’s regulatory authority (product
communications) and that present information not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product.

For the purposes of this guidance and as further explained in section III, information that is consistent with the FDA-required labeling is limited to information about the approved or cleared uses of a product.

FDA is providing this guidance to address frequently asked questions concerning this topic
FDA website
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-FinalFinalThis guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for prescription drugs. The disclosure of the product name in promotional labeling and advertisements is important for proper identification and to ensure safe and effective use.
This guidance also articulates the circumstances under which FDA intends to refrain from taking enforcement action regarding these requirements. FDA believes that following this guidance will allow for appropriate advertising and promotion without presenting any public health risk to patients.
FDA website
Q3B(R) Impurities in New Drug Products (Revision 3)Final, Level 2 revised guidanceThis guidance provides recommendations for registration applications on the content and qualification of impurities in new drug products produced from chemically synthesised new drug substances not previously registered in a region or member state. It revises the ICH guidance of the same title that was issued in May 1997 and first revised in February 2003.FDA website
Benefit-Risk Assessment for New Drug and Biological ProductsDraft Level 1 guidanceThe intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Food and Drug Administration (FDA or Agency) makes about new drug applications (NDAs) submitted under section 505(c) of the FD&C Act as well as BLAs submitted under section 351(a) of the Public Health Service Act (PHS Act).

The guidance first articulates important considerations that factor into the CDER and the CBER benefit-risk assessments, including how patient experience data can be used to inform the benefit-risk assessment.
It then discusses how sponsors can inform FDA’s benefit-risk assessment through the design and conduct of a development program, as well as how they may present benefit and risk information in the marketing application.
It also discusses opportunities for interaction between FDA and sponsors to discuss benefit-risk considerations in connection with the development of an NDA or BLA.
The guidance concludes with additional considerations on benefit-risk assessments that inform regulatory decision-making in the postmarket setting.
FDA website
Investigator Responsibilities – Safety Reporting for Investigational Drugs and DevicesDraft Level 1 guidanceThis guidance is intended to help clinical investigators comply with the following safety

• Investigational new drug application (IND) studies under § 312.64(b) (21 CFR 20 312.64(b))
• Investigational device exemption (IDE) studies under § 812.150 (21 CFR 812.150)

Recommendations are provided to help investigators identify the following:

1. For drugs — Identify safety information that is considered an unanticipated problem
involving risk to human subjects or others and that therefore requires prompt reporting to
institutional review boards (IRBs) under § 312.66 (21 CFR 312.66)

2. For devices — Identify safety information that meets the requirements for reporting
unanticipated adverse device effects (UADEs) to sponsors and IRBs under
32 § 812.150(a)(1) (21 CFR 812.150(a)(1))
FDA website
Electronic Submission Template for Medical Device 510(k) SubmissionsDraftFDA is issuing this draft guidance document to introduce submitters of premarket notification  (510(k)) submissions to the CDRH and CBER to the current resources and associated content developed and made publicly available to support 510(k) electronic submissions to FDA. This  draft guidance is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.FDA website
Questions and Answers on Quality Related Controlled Correspondence Guidance for IndustryDraft Level 2 guidanceThis Q&A guidance applies to generics and provides FDA’s current thinking on quality-related scientific and regulatory topics that appear frequently in controlled correspondence submissions.

The Q&A in the document have been derived from numerous controlled correspondence submissions addressed by the Office of Pharmaceutical Quality. FDA recommend that you review these Q&A before submitting a controlled correspondence for one of the scientific and regulatory topics denoted below
FDA website
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3) Draft Level 2 revised guidance This draft guidance document revises the draft guidance for industry New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) (December 2018) and retains Q.I.12.
This draft guidance does not include new Q&As or make changes to currently issued draft or final Q&As. Additional information about the Q&A format for this draft guidance document is provided in the Background section.

This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.
FDA website
Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry

Revision 2
Final, Level 1 guidance
This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and interchangeable biosimilars, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.
FDA website
Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for IndustryFinal Level 2 guidanceThis document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the European Union, Japan, and United States. This document does not necessarily seek to cover the testing that may be required for registration in, or export to, other areas of the world.
Furthermore, this text presentation serves as a collection of terms, and their definitions, and is not intended to provide direction on how to accomplish validation. These terms and definitions are meant to bridge the differences that often exist between various compendia and regulators of the European Union, Japan, and United States.
FDA website
S12 Nonclinical Biodistribution Consideration For Gene Therapy ProductsDraft Level 1 guidanceThe objective of this guideline is to provide harmonised recommendations for the conduct of  nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products.  This document provides recommendations for the overall design of nonclinical BD assessments. Considerations for interpretation and application of the BD data to support a nonclinical development programme and the design of clinical trials are also provided. The recommendations in this guideline endeavour to facilitate the development of GT products while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles.FDA website
FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health EmergencyFinalFDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. This document updates the guidance of the same title issued in January 2021.
The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.
FDA website