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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.

Events

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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 PUBLIC ADVISORY COMMITTEE MEETING MAY 18

May 10, 2006
KEYWORDS FDAnews Drug Daily Bulletin
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The FDA's Vaccines and Related Biological Products Advisory Committee will hold a meeting May 18 to gather information on the safety and efficacy of Gardasil (Human Papillomavirus [Types 6,11,16,18] Recombinant Vaccine).

The meeting will be from 9 a.m. to 4:45 p.m. in the Hilton Hotel at 620 Perry Parkway, Gaithersburg, Md.

Gardasil, manufactured by Merck, is designed to prevent cervical cancer and genital warts. Merck filed a biologic license application for Gardasil late last year.

In addition, the Vaccine and Related Biological Products Research Review Subcommittee will meet May 19 to discuss the research program at the Office of Vaccines Research and Review, Center for Biologics Evaluation and Research. The meeting will be from 8 a.m. to 4:30 p.m. at the same location as above.