Cover Image

Guidance for industry : considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications.

Bibliographic Details
Corporate Author:	Center for Biologics Evaluation and Research (U.S.)
Format:	Government Document eBook
Language:	English
Published:	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2006]
Subjects:	Developmental toxicology > Government policy > United States. Medicine, Experimental > Government policy > United States. Vaccination > Complications > United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS113605

Similar Items

Guidance for industry : considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications.
Published: (2006)

Guidance for industry : how to complete the vaccine adverse event reporting system form (VAERS-1).
Published: (1998)

Vaccine A : the covert government experiment that's killing our soldiers and why GI's are only the first victims /
by: Matsumoto, Gary
Published: (2004)

Hepatitis B vaccine : helping or hurting public health? : hearing before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, House of Representatives, One Hundred Sixth Congress, first session, May 18, 1999.
Published: (2000)

Guidance for industry : protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators.
Published: (2007)

Vaccine injury compensation : program challenged to settle claims quickly and easily : report to the chairman, Committee on Health, Education, Labor and Pensions, U.S. Senate /
Published: (1999)

Guidance for industry : IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer.
Published: (2004)

Guidance for industry : toxicity grading schedule for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials.
Published: (2007)

Guidance for industry : INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information.
Published: (2003)

Guidance for industry : FDA review of vaccine labeling requirements for warnings, use instructions, and precautionary information.
Published: (2004)

Immunization safety review : vaccinations and sudden unexpected death in infancy /
Published: (2003)

Guidance for industry : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information.
Published: (2001)

The National Vaccine Injury Compensation Program and the Office of Special Masters /
by: Rogers, Hannah-Alise
Published: (2022)

Thimerosal and 2010-2011 seasonal flu vaccines : questions & answers.
Published: (2010)

Evidence of harm : mercury in vaccines and the autism epidemic : a medical controversy /
by: Kirby, David
Published: (2005)

Immunization safety review : SV40 contamination of polio vaccine and cancer /
Published: (2003)

Vaccines--finding the balance between public safety and personal choice : hearing before the Committee on Government Reform, House of Representatives, One Hundred Sixth Congress, first session, August 3, 1999.
Published: (2000)

Guidance for industry : clinical data needed to support the licensure of pandemic influenza vaccines.
Published: (2007)

Guidance for industry : clinical data needed to support the licensure of seasonal inactivated influenza vaccines.
Published: (2007)

Guidance for industry : considerations for plasmid DNA vaccines for infectious disease indications.
Published: (2007)

Liability, licensing and the flu vaccine market : making decisions today to prevent a crisis tomorrow : hearing before the Special Committee on Aging, United States Senate, One Hundred Eighth Congress, second session, Washington, DC, November 16, 2004.
Published: (2005)

Liability, licensing and the flu vaccine market : making decisions today to prevent a crisis tomorrow : hearing before the Special Committee on Aging, United States Senate, One Hundred Eighth Congress, second session, Washington, DC, November 16, 2004.
Published: (2005)

Vaccine supply and innovation /
Published: (1985)

Vaccine information statements.
Published: (1997)

Reviewer guidance : integration of study results to assess concerns about human reproductive and developmental toxicities.
Published: (2001)

The administration's flu vaccine program : health, safety, and distribution : hearing before the Committee on Oversight and Government Reform, House of Representatives, One Hundred Eleventh Congress, first session, September 29, 2009.
Published: (2009)

The administration's flu vaccine program : health, safety, and distribution : hearing before the Committee on Oversight and Government Reform, House of Representatives, One Hundred Eleventh Congress, first session, September 29, 2009.
Published: (2009)

Memorandum report : repeat pneumococcal vaccinations for Medicare beneficiaries.
Published: (2013)

Coordinated strategy to accelerate development of vaccines for infectious diseases : report to Congress.
Published: (2009)

The measles : background and federal role in vaccine policy /
by: Barry, Matthew B., et al.
Published: (2018)

Key facts about seasonal flu vaccine.
Published: (2010)

National vaccine plan implementation : protecting the nation's health through immunization /
Published: (2010)

Proceedings of a Workshop on Vaccine Innovation and Supply : report /
Published: (1986)

Vaccine safety.
Published: (2021)

New vaccine development : establishing priorities.
Published: (1985)

Vaccines : saving lives, ensuring confidence, and protecting public health : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Sixteenth Congress, second session on examining vaccines, focusing on saving lives, ensuring confidence, and protecting public health, September 9, 2020.
Published: (2022)

Information sheet : guidance for institutional review boards and clinical investigators (recruiting study subjects).
Published: (1998)

Immunization safety review : vaccines and autism /
Published: (2004)

Guidance for industry : street drug alternatives.
Published: (2000)

Information sheet : guidance for institutional review boards and clinical investigators (screening tests prior to study enrollment).
Published: (1998)