New Guidance Documents and Annual Public Meeting of the Reagan-Udall Foundation for the FDA

1. Special Protocol Assessment: Guidance for Industry

This guidance provides information on the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA). SPA is a process in which sponsors may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval.

2. Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

This draft guidance describes policies that FDA proposes to use in evaluating bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for inclusion on the list of bulk drug substances that can be used in compounding under section 503B.

3. Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs Guidance for Industry

This guidance addresses FDA’s current thinking about the relevant age groups to study and how early in a drug’s development pediatric patients should be incorporated during development of systemic drugs for atopic dermatitis (AD). The recommendations in this guidance are based on input received from the March 9, 2015, Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) meeting on this topic and review of medical literature and relevant statutes and regulations.  

4. Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry

This guidance provides recommendations about how and when to include pregnant women in drug development clinical trials for drugs and therapeutic biological products based on the FDA’s current thinking on this subject.  Specifically, this guidance supports an informed and balanced approach to gathering data on the use of drugs and biological products during pregnancy through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk.  

5. E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population Guidance for Industry

The purpose of the addendum is to complement and provide clarification and current regulatory perspective on topics in pediatric drug development.

6. Annual Public Meeting; Reagan-Udall Foundation for the FDA

FDA Commissioner Scott Gottlieb will be the keynote speaker at the 2018 annual public meeting of the Reagan-Udall Foundation for the FDA. Mark your calendars for Friday, May 4th from 10am to noon; the event is free and open to the public. The Foundation will discuss its activities and how it supports the FDA and former FDA Commissioners will conduct a panel discussion on the "Evolution of FDA Science and Engagement." 

There is an oral comment period at the end of the meeting, limited to three minutes per attendee. Please email Elisabeth Shaefer at eshaefer@reaganudall.org by May 2, 2018 if you intend to make an oral comment at the meeting. The public is also invited to submit written comments to the Foundation in advance by emailing them to eshaefer@reaganudall.org before May 3rd.

The public meeting will be held at the law offices of Alston and Bird, 950 F St. NW, Washington DC. Seating is limited so register to attend the meeting by 5:00 p.m, May 3rd via the meeting webpage.

Federal Register Notice