Regulation and Compliance - BioPharm International

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Regulation and Compliance

Developing an International Dialogue on Biologics Standards

August 1, 2011

US Pharmacopeia promotes horizontal standards and a product-class approach for quality attributes.

Impact of cGMP on Supply Chain

July 1, 2011

Incorporating regulatory requirements into the product life cycle is crucial.

FDA and Manufacturers Ponder Biosimilars Pathway

July 1, 2011

Follow-on versions of complex biologics require extensive expertise.

Safety Concerns and Shortages Challenge Pharma Manufacturing

June 1, 2011

Industry struggles to curb drug abuse, diversion, and disruptions in supply to ensure access to quality products.

Quality by Design: The Case for Change (Part II)

May 1, 2011

A rigorous cost-benefit assessment can help to chart a cost-effective path forward.

Filling the Pharma Pipeline

May 1, 2011

FDA, NIH, and industry seek new strategies to spur drug development and promote access to therapies.

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.

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