Preparation of Chemicals and Bulk Drug Substance for the U.S. Army Drug Development Program

2000 ◽  
Author(s):  
Jaroslav Novotny
Keyword(s):  
Drug Development ◽  
Development Program ◽  
Drug Substance ◽  
Bulk Drug ◽  
Drug Development Program ◽  
The U.S

The U.S. Army Drug Development Program

Chemotherapy ◽  
1979 ◽  
pp. 99-108
Author(s):  
Craig J. Canfield ◽  
Melvin H. Heiffer
Keyword(s):  
Drug Development ◽  
Development Program ◽  
Drug Development Program ◽  
The U.S

Preparation of Chemical Compounds for the U.S. Army Drug Development Program

1990 ◽  
Author(s):  
P. Blumbergs ◽  
L. V. Dunkerton ◽  
B. S. Ross ◽  
D. A. Greening ◽  
D. J. Dagli ◽  
...  
Keyword(s):  
Drug Development ◽  
Development Program ◽  
Chemical Compounds ◽  
Drug Development Program ◽  
The U.S

scholarly journals FDA relations during drug development

2000 ◽  
Vol 2 (3) ◽  
pp. 213-217
Keyword(s):  
Drug Development ◽  
Drug Application ◽  
Development Program ◽  
The United States ◽  
Legal Aspects ◽  
Development Programs ◽  
New Drug ◽  
Regulatory Affairs ◽  
New Drug Application ◽  
Drug Development Program

Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pre-new drug application (pre-NDA) submission phases. Appropriate informal discussions via fax and telephone are also encouraged. By proactively interacting with the FDA, the pharmaceutical industry increases the probability of a successful drug development program.

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