BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 8.09.2000

Draft “Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications;” Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications" dated August 2000. The draft guidance document provides information to sponsors regarding assessment of the reproductive toxicity potential of preventive vaccines for infectious diseases. The draft guidance document, when finalized, is intended to provide sponsors with guidance for the conduct of reproductive toxicity studies for preventive vaccines and to consider establishing clinical pregnancy registries for preventive vaccines indicated for females of childbearing potential and pregnant individuals.

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