Regulation and Compliance - BioPharm International

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Regulation and Compliance

Vaccine Innovation Yields New Products and Processes

March 1, 2013

Vaccine development is benefiting from manufacturing advances.

Europe and the United States to Negotiate a Free-Trade Agreement

March 1, 2013

Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.

Standards-Setting Activities on Impurities

March 1, 2013

USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.

GMP Compliance Becomes Prominent Enforcement Issue

February 1, 2013

Shortages spur efforts to overhaul manufacturing oversight.

Falsified Medicines Directive Takes Shape in Europe

January 1, 2013

The EU fine-tunes the Falsified Medicines Directive.

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.

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