Content and Format of Labeling for Human Prescription Drugs; Pregnancy Labeling; Public Hearing; Reopening of Comment Period

الملخص

The Food and Drug Administration (FDA) is reopening the comment period following its September 12, 1997, public hearing until January 12, 1998. This public hearing, which was announced in the Federal Register of July 31, 1997 (62 FR 41061), focused on requirements for the content and format of the pregnancy subsection of labeling for human prescription drugs. The comment period closed on November 12, 1997. This action is being taken in response to the request of the Pharmaceutical Research and Manufacturers of America for additional time to prepare comments because of the complexity and importance of the issues raised by pregnancy labeling.