Vaccine INDs: review of clinical holds-Reference-Cited by-同舟云学术

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Vaccine INDs: review of clinical holds

Published:2005-01 Issue:9 Volume:23 Page:1099-1101
ISSN:0264-410X
Container-title:Vaccine
language:en
Short-container-title:Vaccine

Author:

Miller Daryll L.,Ross Jennifer J.

Publisher

Elsevier BV

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health,General Veterinary,General Immunology and Microbiology,Molecular Medicine

Reference4 articles.

1. Public Health Service Act Section 351, 1944.

2. Code of Federal Regulations (CFR), Title 21, Part 312, U.S. Government Printing Office, Washington, DC, 2003.

3. Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA, Products, 2000, http://www.fda.gov/cber/guidelines.htm.

4. CDC, 2003, http://www.bt.cdc.gov/agent/agentlist-category.asp.

Cited by 8 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Emerging trends of edible vaccine therapy for combating human diseases especially COVID ‐19: Pros, cons, and future challenges;Phytotherapy Research;2022-05-02

2. An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products;Regulatory Toxicology and Pharmacology;2020-02

3. Clinical Trial Authorization and Investigational New Drug Applications;Fundamentals of Biologicals Regulation;2018

4. Investigational New Drug applications: a 1-year pilot study on rates and reasons for clinical hold;Journal of Investigative Medicine;2016-01-28

5. Gene therapy for cancer: regulatory considerations for approval;Cancer Gene Therapy;2015-11-20

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