Placeholder Banner

BIO Comments on FDA Draft Guidance on Postapproval Pregnancy Safety Studies

July 1, 2019

BIO submitted comments on the Food and Drug Administration (FDA) Draft Guidance on Postapproval Pregnancy Safety Studies.

BIO expresses support for the goal of enhancing the medical community’s knowledge of the effects of medicines on pregnant women. In addition, BIO commends the FDA for welcoming the use of other types of post-approval studies other than pregnancy registries to monitor the safety of products during pregnancy.

BIO notes the majority of the guidance is focused on pregnancy registries, implying they are the default mechanism for conducting pregnancy surveillance after marketing. BIO urges FDA to consider amending the guidance and consider all possible limitations of pregnancy registries and all possible methods of pregnancy surveillance as well as the use of existing systems to collect and evaluate pregnancy information, such as pharmacovigilance studies.

Download Full Comments Below
BIO Letter Post Appoval Pregnacny Safety Study FDA-2018-D-4693
Read the full comments below
Discover More
January 7, 2020 Re: Docket No. FDA–2019-N-3453: Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs Dear Sir/Madam: The Biotechnology Innovation Organization (BIO…
The Biotechnology Innovation Organization provided comments to the Treasury Department and Internal Revenue Service on proposed regulations under Section 382 with respect to the built-in gain and built-in loss rules of Section 382(h).
In a recent letter, BIO’s Jim Greenwood commended Representative Steil (R-WI) for introducing the “Helping Startups Continue to Grow Act,” which extends the exemption afforded to Emerging Growth Companies under the JOBS Act from certain executive…