Articles by Robert Iser - Pharmaceutical Technology

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Articles by Robert Iser

Robert Iser


Robert Iser, M.S., 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.

Articles
FDA Perspectives: Common Deficiences in Abbreviated New Drug Applications (Part 4)
April 2, 2011

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.

FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 3 - Control of the Drug Product and Stability
February 2, 2011

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

FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 2: Description, Composition, and Excipients
August 2, 2010

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.

FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 1: Drug Substance
January 2, 2010

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

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