Regulation and Compliance - BioPharm International


Regulation and Compliance

USP Hosts Symposium on Science and Standards

September 5, 2012

USP Hosts Symposium on Science and Standards

Campaign Mounts to Curb Counterfeit Drugs

September 1, 2012

Manufacturers and regulators struggle to control phony versions of crucial medicines.

FDA User-Fee Legislation

August 1, 2012

Import controls and risk strategies aim to promote quality and spur new drug development.

Biotech Innovation Gains Support in Washington

July 1, 2012

Multiple initiatives are moving forward to maintain US leadership in biopharm R&D.

Interview with FDA: Adopting New Strategies to Oversee Global Economy

June 1, 2012

In a special anniversary interview, Washington Editor Jill Wechsler speaks with with FDA Deputy Commissioner Deborah Autor about where the agency is headed.

FDA Explores Options to Expand Access to NonPrescription Drugs

May 1, 2012

Manufacturers seek clear path to develop safe-use approaches for more risky OTC therapies.

Manufacturers Wrestle with Drug Abuse and Critical Shortages

April 1, 2012

Soaring opioid use creates challenges for new drug development and supply-chain control.

Communications Advances Present Challenges to Manufacturers

March 1, 2012

Social media use raises questions about applying old standards to new information technology.

FDA and Justice Department Address Drug Quality Concerns

February 1, 2012

More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.



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