Regulation and Compliance - BioPharm International


Regulation and Compliance

Congress to Scrutinize FDA Rules, Research Policies

February 1, 2011

FDA prepares for top-level changes while promoting transparency and product safety

Costs and Compliance Dominate Agenda for 2011

January 1, 2011

Top priorities for manufacturers include user fees, new health initiatives, and regulatory compliance.

Biotech Manufacturers Face New Political Landscape

December 1, 2010

Changes on Capital Hill create uncertainty for healthcare reform, drug regulation, and biomedical research.

Time to Revisit Supplier Quality Management

November 1, 2010

Best practices to strengthen supplier quality management.

Biotech Manufacturers Anticipate CER Challenges

November 1, 2010

Comparative effectiveness poses challenges for drug manufacturers.

Biotech Companies Gain Support for Vaccine, Countermeasure Production

October 1, 2010

A new strategy to streamline vaccine development and oversight.

Quality Management Systems for Small Biopharmaceutical Organizations

September 1, 2010

What small biotechs need to know about quality management systems.

REMS Program Challenges Manufacturers, Providers

September 1, 2010

Too many REMS cause headaches for doctors and the industry.

Manufacturing Compliance in the Spotlight

August 1, 2010

Plant closures, product recalls prompt FDA re-evaluation of GMP enforcement efforts.



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