Regulation and Compliance - BioPharm International

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Regulation and Compliance

Manufacturers Wrestle with Drug Abuse and Critical Shortages

April 1, 2012

Soaring opioid use creates challenges for new drug development and supply-chain control.

Communications Advances Present Challenges to Manufacturers

March 1, 2012

Social media use raises questions about applying old standards to new information technology.

FDA and Justice Department Address Drug Quality Concerns

February 1, 2012

More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.

Auditing by the Numbers

January 1, 2012

Contract organizations must have highly organized teams and plans to accommodate today's audits.

Budget Crunch, Political Battles Shape Policy Agenda for Year

January 1, 2012

Pressure to approve new user fees opens the door to action on drug shortages, prices, and regulation.

FDA Revamps to Meet New Challenges

December 1, 2011

Added responsibilities and outside concerns prompt overhaul of agency's structure.

Developing and Sustaining a Quality Culture

November 1, 2011

In a culture of quality, it is important that employees adopt this mindset, not because they have to, but because they understand the importance.

Drug Shortages Create Crisis for Manufacturers, Regulators

November 1, 2011

Clamor mounts over compromised care and rising costs due to lack of crucial therapies.

Global Health Challenges Spur Vaccine Development

October 1, 2011

Manufacturers fund research and reduce prices to tackle diseases around the world.

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