Regulation and Compliance - BioPharm International


Regulation and Compliance

Research Policies Pose New Challenge for US Administration

December 1, 2012

White House and Congress likely to struggle over funding for bio/pharmaceutical regulation.

Product Analysis Key to Biosimilar Development

November 1, 2012

Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.

New Era for Generic Drugs

October 1, 2012

User fees aim to speed approvals and support inspections.

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.



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