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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

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Jan 29

Developing Pharmaceutical Investigational Brochures & Annual Reports: Secrets to Practical Succes...

Jan 30

Regulating Software Used by Life Science Manufacturers: Is it a Medical Device or Not?

Feb 13

Building a World-Class Drug Supply Chain: Tips for Compliance and Digital Transformation

Feb 19

Medical Device Risk Management: Prepare for the Winds of Change

Mar 20

Medical Device Complaint Management: Escape the Labyrinth

Mar 26

Conducting Advanced Root Cause Analysis and CAPA Investigations

Editor's Picks

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Gramercy’s Nitinol Staple System Cleared by FDA

The device provides an array of sterile symmetric and asymmetric, barbed and smooth staples.
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Stakeholders Offer Feedback on New National Drug Code Format

Among other options, the agency proposed a new, expanded 12-digit format.
FDAnews Drug Daily Bulletin

FDA NAMES NEW DIRECTOR OF OFFICE OF COMPLIANCE

June 23, 2006
KEYWORDS FDAnews Drug Daily Bulletin
A A

Deborah M. Autor will be the new director of CDER's Office of Compliance, the FDA announced recently.

Autor joined the Office of Compliance in 2001 as a senior adviser and has been the office's associate director for compliance policy since 2002. She led the reintegration of the Division of Scientific Investigations into the Office of Compliance and has been instrumental in spearheading the FDA's initiative to deal more aggressively with unapproved drugs, said the agency.

Prior to her work at CDER, Autor was a trial attorney in the Department of Justice's Office of Consumer Litigation, where she prosecuted civil and criminal cases under the Federal Food, Drug and Cosmetic Act.