Articles by Robert Iser - Pharmaceutical Technology

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Articles by Robert Iser

FDA Perspectives: Common Deficiences in Abbreviated New Drug Applications (Part 4)

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.
Apr 2, 2011
By: Aloka Srinivasan, Robert Iser

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

Chemistry reviewers in the FDA's Office of Generic Drugs provide an overview of common deficiencies cited throughout the CMC section of ANDAs
Feb 2, 2011
By: Aloka Srinivasan, Robert Iser, Devinder S. Gill

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

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.
Aug 2, 2010
By: Aloka Srinivasan, Robert Iser, Devinder S. Gill

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

Team leaders in FDA's Office of Generic Drugs provide an overview of common deficiences cited throughout the CMC section of abbreviated new drug applications.
Jan 2, 2010
By: Aloka Srinivasan, Robert Iser

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

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