Aloka Srinivasan

Aloka Srinivasan, PhD, is a team leader at the Office of Generic Drugs within the Office of Pharmaceutical Science under the US Food and Drug Administration's Center for Drug Evaluation and Research.

FDA reviewers aim to assist ANDA sponsors in building quality into their submissions by clarifying components of the applications. Part 4 addresses manufacture and container closure.

Chemistry reviewers in FDA's Office of Generic Drugs provide an overview of common deficiencies cited throughout the CMC section of ANDAs.

FDA chemistry reviewers in the Office of Generic Drugs provide an overview of common deficiences cited throughout the Chemistry, Manufacturing, and Controls section of ANDAs.

Team leaders in FDA's Office of Generic Drugs provide an overview.