Regulation and Compliance - BioPharm International


Regulation and Compliance

Health-Reform Controversies

April 1, 2011

Courts and Congress seek to reshape policies and programs affecting drug costs and access.

Drug Safety and Shortages Challenge Manufacturers

March 1, 2011

As drug shortages make headlines, FDA tests the Sentinel safety system and its effect on healthcare.

Quality by Design: The Case for Change

March 1, 2011

Executive management leadership is essential in the effective implementation of QbD.

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.



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