Pregnancy Labeling Information

Pregnancy Labeling (21CFR201.57).

The National Archives and Records Administration has made current and previous versions of the Code of Federal Regulations (CFR) available on-line. This link searches the CFR by citation. Enter the following citation information: Title 21, Part 201 and Section 57 then click RETRIEVE for the pregnancy labeling section.

PhRMA Letter - June 30, 1998

Letter from PhRMA's DRUSAFE Pregnancy Labeling Subcommittee (preclinical) and the Pregnancy Labeling Task Force (clinical) to the FDA Center for Drug Evaluation and Review. This letter discusses concerns about the pregnancy labeling proposals drafted by the FDA.

Eli Lilly and Company - January 7, 1998

Supplemental comments from Eli Lilly's testimony at the Public Hearing on Pregnancy Labeling held by FDA on September 12, 1997.

J. DeGeorge, et al. - November, 1997

Suggested Changes and Redesign of the Pregnancy Label for Human Drugs.

Proposal developed by an ad hoc group within the Center for Drug Evaluation and Research of the FDA to encourage discussion and open dialogue about pregnancy labeling.

S. Kweder and A. Sciall - November, 1997

Proposed Changes to the Pregnancy Section of Labels for New Drugs and Biologic Products.
This proposal describes an approach to labeling drugs and products for use during pregnancy in response to issues raised at the Public Hearing on Pregnancy Labeling held by FDA on September 12, 1997.

Public Hearing: - September, 1997.

Part 15 Public Hearing on Pregnancy Labeling CFR 201.57.
The purpose of this public hearing held by the FDA was to discuss the content and format of labeling on the package insert concerning use during pregnancy. A brief presentation on the background of the pregnancy labeling categories is also included.

Other References:

Sannerstedt R, et al., Drugs during pregnancy: an issue of risk classification and information to prescribers. Drug Saf. 14(2): 69-77, 1996.

Teratology Society Public Affairs Committee FDA Classification of Drugs for Teratogenic Risk. Teratology 49: 446-447, 1994.

Millstein LG. FDA's "pregnancy categories". N Engl J Med. 303 (12): 706, 1980.