Regulation and Compliance - BioPharm International

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Regulation and Compliance

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.

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.

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.

Corrective and Preventative Action Programs: A Mechanism of Control

March 1, 2010

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

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