Study Approaches and Methods To Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting; Public Meeting, Request for Comments

The Food and Drug Administration (FDA) is announcing a public meeting entitled ‘‘Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting.’’ The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing pregnancy registries and other methods of evaluating the post-approval safety profile of drugs and biological products in pregnant women.

Date(s) and Time:

May 28, 2014 - 8:00 a.m. to 5:00 p.m.
May 29, 2014 - 8:00 a.m. to 1:15 p.m.

Location:

FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Conference Center, the Great Room (Rm. 1503)
Silver Spring, MD 20993

For information on transportation, parking, hotels, visitor access, and more, please visit: Public Meetings at the FDA White Oak Campus

• Federal Register Notice
• Meeting Agenda (PDF - 43KB)
• Background Information (PDF - 93KB)
• Biographical Sketches for Panelists (PDF - 44KB)
• Disclosure Forms
• Final Panelist Meeting Roster (PDF - 48KB)

Webcast Information

Links to the archived webcast of the Public Meeting are now available: 

Wednesday, May 28, 2014

• https://collaboration.fda.gov/p7md1drjhpe/
• https://collaboration.fda.gov/p1b5a1prf4j/
• https://collaboration.fda.gov/p5tujqkoqga/
• https://collaboration.fda.gov/p1yji13t0ds/

Thursday, May 29, 2014

• https://collaboration.fda.gov/p42ec9wu74i/
• https://collaboration.fda.gov/p9p5lg4crjc/

Transcripts from the Meeting

Wednesday, May 28, 2014

• Morning Session (PDF - 1.32MB)
• Afternoon Session (PDF - 1.22M) 

Thursday, May 29, 2014

• Full Session (PDF - 1.85MB) 

For questions related to registration, oral presentations and other meeting logistics

Please contact Cherice Holloway at cherice.holloway@fda.hhs.gov, or by telephone at: 301–796–4909

Presentations

Please see FDA Archive for presentations below.

• Jessica Albano, PhD, MPH
• Lewis Holmes, MD
• Sonia Hernandez-Diaz, MD
• Christina Chambers, PhD, MPH
• Michael Greene, MD
• Allen Mitchell, MD
• Susan Andrade
• Allison Naleway, PhD
• Adrian Dana, MD
• Solomon Iyasu, MD, MPH
• Adel Abou-Ali, PharmD, ScD, MD
• Leyla Sahin, MD, FACOG
• Kimberly Thomas, MPH
• Conlin, Coster, Thelus