WASHINGTON, May 11 -- Food and Drug Administration has issued a notice called: Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability.
The notice was published in the Federal Register on May 11 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Postapproval Pregnancy Safety Studies." The purpose of this guidance will be to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes in pregnant women exposed to drug and biological products regulated by FDA ( i.e, pregnancy safety studies) in the postap...