March 1, 2024

Dear Colleague,

While the FDA continues to focus on protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products, we also recognize the work of our public health partners. As public health advocates, we know that your work to better our country is invaluable. Your partnership, knowledge and engagement in the public health space are appreciated.

Updates

• February 28, 2024 - FDA, Industry Actions End Sales of PFAS Used in US Food Packaging
• February 27, 2024 - FDA Roundup
• February 26, 2024 - Setting and Implementing Standards for Narrow Therapeutic Index Drugs
• February 26, 2024 - Remarks by Commissioner Robert Califf to the AIRIS Workshop
• February 23, 2024 - FDA Roundup

Spotlight!

FDA Voices

FDA Helps to Deliver Meaningful Advances for Rare Disease Patients

Advancing the understanding of rare diseases and innovative tools to support product development is part of the FDA's commitment to promoting safe, effective treatment options for patients.

Guidance Documents

Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry

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.

Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards

This draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule) by the U.S. Department of Health and Human Services (HHS) and identical provisions in FDA’s proposed rule “Protection of Human Subjects and Institutional Review Boards.” The FDA’s proposed rule, if finalized, would harmonize certain sections of FDA’s regulations on human subject protections and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Common Rule, in accordance with the 21st Century Cures Act. The guidance addresses the provisions of the revised Common Rule that require informed consent to begin with key information about the research and to present information in a way that facilitates understanding and identical provisions in FDA’s proposed rule.

Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide

FDA is issuing this Technical Conformance Guide (guide) to assist registrants of drug establishments (or their authorized agents) in submitting reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

View all Official FDA Guidance Documents and other Regulatory Guidance
You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

Webinars and Virtual Workshops

FDA Rare Disease Day 2024

March 1, 2024; 9 a.m. - 4:30 p.m. ET

This year’s Rare Disease Day is dedicated to patients and health care professionals. Panels will discuss:

• The legal framework for approving studies and medical products at FDA
• What FDA does during review processes to approve medical products
• Decentralized clinical trials and digital health technologies
• Where to find important information and documents related to clinical trials
• Information that can be obtained from medical product labels
• Legal and ethical requirements for consent forms in clinical trials
• FDA initiatives to advance medical product development for rare diseases
• Ways for patients to engage with FDA

Vaccines and Related Biological Products Advisory Committee Meeting

March 5, 2024; 9 a.m. - 3:30 p.m. ET

The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2024 to 2025 influenza season.

Rare Neurodegenerative Disease Efforts Under the ACT for ALS

March 8, 2024; 12:30 p.m. - 2:40 p.m. ET

This hybrid meeting will provide an opportunity to share the 2024 priorities for Critical Path for Rare Neurodegenerative Diseases (CP-RND) program to provide an update on efforts from the Food and Drug Administration (FDA) and National Institutes of Health (NIH) focused on rare neurodegenerative diseases.

FDA Grand Rounds: Evaluating Mutagenicity by Error-corrected Sequencing

March 14, 2024; 12:00 p.m. - 1:00 p.m. ET

Somatic mutations are permanent and heritable genetic alterations that increase cancer risk. They can occur spontaneously but most often result from DNA damage induced by the environment (e.g., sunlight) or genotoxic compounds (e.g., chemical mutagens).

View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

About Us

The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov.