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2010-09-22
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Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications; Availability
Notices
D09002ee1bde24483
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United States
Department of Health and Human Services
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United States
Food and Drug Administration
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United States Government Agency or Subagency
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 This guidance document finalizes the draft guidance entitled ``Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications,'' dated August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.
71 FR 7779
https://www.govinfo.gov/app/details/FR-2006-02-14/E6-1998
E6-1998
fr14fe06-66
4160-01-S
Docket No. 2000D-1400
https://www.govinfo.gov/app/details/FR-2006-02-14/E6-1998
https://www.govinfo.gov/content/pkg/FR-2006-02-14/html/E6-1998.htm
https://www.govinfo.gov/content/pkg/FR-2006-02-14/pdf/E6-1998.pdf
2 p.
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71 FR 7779
Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications; Availability; Federal Register Vol. 71, Issue
NOTICE
E6-1998
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 2000D-1400
4160-01-S
E6-1998
Notice.
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.
Submit written or electronic comments on agency guidances at any time.
Astrid Szeto, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.
Reports and guidance documents; availability, etc.:
Preventative and therapeutic vaccines for infectious disease indications; developmental toxicity studies,
http://www.fda.gov/cber/guidelines.htm
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets/default.htm
Federal Register
Vol. 71, no. 30
Office of the Federal Register, National Archives and Records Administration
2006-02-14
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2006-02-14
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0042-1219
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769-004-00000-9
000582072
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https://www.govinfo.gov/app/details/FR-2006-02-14
https://www.govinfo.gov/content/pkg/FR-2006-02-14/pdf/FR-2006-02-14.pdf
https://www.govinfo.gov/content/pkg/FR-2006-02-14/xml/FR-2006-02-14.xml
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