Common Deficiences in Abbreviated New Drug Applications: Part II: Description, Composition, and Excipients

Authors :: Srinivasan, Aloka
Iser, Robert
Gill, Devinder S.
Source :: Pharmaceutical Technology. July 2011, Vol. 35 Issue 7, pS214, 5 p.
Publication Year :: 2011
Abstract: Chemistry reviewers in the US Food and Drug Administration's Office of Generic Drugs provide an overview of common deficiences cited througout the Chemistry, Manufacturing, and Controls section of abbreviated new [...]

Subjects :: United States. Food and Drug Administration -- Powers and duties
Management
Powers and duties
Company business management
Drugs -- Management
Pharmaceutical industry -- Management
Excipients -- Management

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