J D Pessetto

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The development and implementation of a Quality Assurance (Q.A.) program based on desired outcomes for a Pharmaceutical Production Services area is discussed. The article describes the determination of desired outcomes and how to put the criteria into a workable audit format. A sample audit, along with actual results obtained, illustrate the kinds of(More)
The purpose and use of the FDA's classification system for new drug products are described. Investigational new drug applications (INDs) and new drug applications (NDAs) are submitted to the FDA's Center for Drug Evaluation and Research. To establish the priority of the product in the review process, expert reviewers classify each product according to(More)
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