Vaccine INDs: Review of clinical holds

Vaccine

Volumn 23, Issue 9, 2005, Pages 1099-1101

  Miller, Daryll L ^a   Ross, Jennifer J ^a  

^a Ctr Biologics Eval Res Food D   (United States)

Author keywords

Clinical hold; Pre IND; Vaccine IND

Indexed keywords

VACCINE;

CORRELATION ANALYSIS; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNIZATION; MEDICAL INFORMATION; MEDICAL RESEARCH; PREVENTIVE HEALTH SERVICE; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT;

EID: 11144244446     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2004.08.038     Document Type: Article

References (4)

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.