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Zdrowie i gospodarka · 14.02.2006

Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications; Availability

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications," dated February 2006. The guidance is intended to provide sponsors with recommendations for the conduct of developmental toxicity studies for investigational preventive and therapeutic vaccines for infectious disease indications. The recommendations pertain to the assessment of the developmental toxicity potential of preventive and therapeutic vaccines for infectious diseases indicated for females of childbearing potential and pregnant individuals. This guidance document finalizes the draft guidance entitled "Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications," dated August 2000.

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