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Latest News

July 1st 2006

Regulatory Beat: Nanotechnology Presents Opportunities and Challenges for FDA and Manufacturers

Food and Drug Administration is encouraging public–private collaborations to more fully explore the physical and chemical characteristics of nanoparticles.

June 1st 2006

Regulatory Beat: FDA's Field Force Does More With Less

By Jill Wechsler

May 1st 2006

Regulatory Beat: FDA Encourages Innovation in Biotech Manufacturing and Product Development

By Jill Wechsler

April 1st 2006

Regulatory Beat: FDA and Industry Seek New Strategies to Curb Counterfeiting and Diversion

By Jill Wechsler

February 1st 2006

Regulatory Beat: FDA Moves to Renew User Fees and Promote Preparedness

By Jill Wechsler

Qualifying Network Infrastructure - A Risk-Based Approach

ByLudwig Huber

February 15th 2004

Networks are part of the compliance picture. Recent FDA warning letters show the agency considers network monitoring and qualification a necessary part of maintaining the security and integrity of electronic records.