Regulation and Compliance - BioPharm International

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Regulation and Compliance

How to Reduce Unnecessary Compliance Costs

July 1, 2010

By identifying and eliminating non-value-added activities, drug manufacturers can avoid falling into the same cost-traps in the future.

FDA Seeks Transparency in Data and Decisions

July 1, 2010

More information may be available on drug approvals, prices, and research to expand public understanding of regulatory policies.

Manufacturers, FDA Seek to Secure Supply Chains

June 1, 2010

International outsourcing and rising theft spur regulatory action and manufacturer oversight.

Healthcare Reform Expands Coverage, Promotes Innovation

May 1, 2010

Broader benefits and biosimilars will offset hefty fees and discounts while preserving R&D incentives.

REMS Raise Concerns for Biotech Products

April 1, 2010

The FDA is expanding postmarketing safety requirements, despite limited resources to manage these added responsibilities.

Corrective and Preventative Action Programs: A Mechanism of Control

March 1, 2010

An effective CAPA plan provides a mechanism for responding to the unexpected.

FDA Seeks More Timely Drug Information Electronically

March 1, 2010

The new Sentinel system aims to expand access to data on medical product safety and patient effects.

Biotech Manufacturing Under Scrutiny

February 1, 2010

Trouble at Genzyme and with flu vaccine production illustrates the challenges in producing safe and potent biologics.

Issues and Opportunities Challenge Biotech Manufacturers

January 1, 2010

Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.

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