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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
This guidance is intended to provide you, sponsors, with recommendations for the conduct of developmental toxicity 2 studies for investigational preventive and therapeutic vaccines for infectious disease indications. The recommendations set forth in this document 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.3 This guidance applies prospectively to investigational vaccines, i.e., vaccines under investigational new drug applications (IND) and vaccines the subject of a new biologics license
application (BLA). These recommendations do not apply retrospectively to already licensed vaccines except those the subject of additional INDs. This guidance document finalizes the draft guidance entitled “Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications” dated August 2000 (65 FR 54534; September 8, 2000).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: 2000D-1400.