New FDA drug approval policies and HIV vaccine development
Bibliographic Data
| ID | 11040282 |
|---|---|
| Authors | Wendy K Mariner (0000-0001-5176-5917, Boston University, corresponding author) |
| Year | 1990 |
| Volume | 80 |
| Issue | 3 |
| Pages | 336-341 |
| Publication date | 1990-03-01 |
| Peer Reviewed | Yes |
| Open Access | No |
| Type | ARTICLE |
| Venue | American Journal of Public Health (JOURNAL) |
| Journal identifiers | ISSN: 0090-0036 • E-ISSN: 1541-0048 |
| Publisher | American Public Health Association (PUBLISHER • US) |
| DOI | 10.2105/ajph.80.3.336 |
| PMID | 2305921 |
| OpenAlex | W2081314434 |
| Language | EN |
| References cited | 29 |
Conducted a study of Food and Drug Administration (FDA) law and policy including interviews with FDA officials in the Center of Biologics Evaluation and Research and the Office of the General Counsel. Suggests that the new FDA drug review policies do not fit vaccines. Instead, the nature of vaccines, and HIV vaccines in particular, argues for adherence to a more rigorous form of review. (JLN)
Drug · Drug approval · Drug development · Family medicine · HIV vaccine · Human immunodeficiency virus (HIV) · Vaccine trial · HIV Research and Treatment · HIV/AIDS drug development and treatment · HIV/AIDS Research and Interventions · Medicine · Pharmacology · Virology
| Citation velocity | historical |
|---|---|
| Highly cited | No |