Regulation and Compliance - BioPharm International

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Regulation and Compliance

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.

Developing an International Dialogue on Biologics Standards

August 1, 2011

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

FDA Maps Strategy to Counter Supply-Chain Threats

August 1, 2011

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

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.

Filling the Pharma Pipeline

May 1, 2011

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

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.

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