Regulation and Compliance - BioPharm International

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Regulation and Compliance

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.

Manufacturers and FDA Gear Up for User-Fee Action

September 1, 2011

PDUFA renewal legislation sets stage for new policies affecting revenue, research, and oversight.

Following Our Own Instructions

September 1, 2011

Why SOPs are rarely followed, often cited, and in great need of follow-through.

FDA Maps Strategy to Counter Supply-Chain Threats

August 1, 2011

Rising imports, overseas production spur collaboration and realignment of enforcement activities.

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