Regulatory Beat - BioPharm International

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Regulatory Beat

Regulatory Convergence Sought for Global Pharma Market

May 1, 2013

Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.

Manufacturers Under Pressure to Manage Painkillers

April 1, 2013

Opioid abuse generates calls for efforts to curb distribution.

Vaccine Innovation Yields New Products and Processes

March 1, 2013

Vaccine development is benefiting from manufacturing advances.

GMP Compliance Becomes Prominent Enforcement Issue

February 1, 2013

Shortages spur efforts to overhaul manufacturing oversight.

Drug Quality at Center Stage for FDA and Manufacturers

January 1, 2013

Shortages spur efforts to overhaul manufacturing oversight.

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.

Campaign Mounts to Curb Counterfeit Drugs

September 1, 2012

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

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