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Zdrowie i gospodarka · 4.06.1999

Draft Guidance for Industry on Establishing Pregnancy Registries; Availability

The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled ``Establishing Pregnancy Registries.'' Pregnancy registries are recognized as one method of obtaining meaningful information on the risks associated with exposure to drugs or biologics during pregnancy. The draft guidance is intended to provide sponsors with guidance on establishing pregnancy registries that help ensure the quality and integrity of registry data and adequately document registry research methods. The draft guidance will be discussed during the June 3, 1999, meeting of the Subcommittee of the Advisory Committee for Reproductive Health Drugs.

Source: Federal Register — Food and Drug AdministrationOpen original release →