Regulation and Compliance - BioPharm International

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Regulation and Compliance

FDA Takes Actions to Prevent Drug Shortages

November 1, 2013

FDA releases a strategic plan and issues a proposed notification rule to improve prevention and resolution of drug shortage problems.

USP Plans Standards on Good Distribution Practices

November 1, 2013

USP is developing and revising distribution standards in response to changes in the global supply chain.

FDA Publishes ANDA Submission Guidance

September 30, 2013

FDA publishes guidance on ANDA submissions.

European Medicines Agency Reorganizes

September 17, 2013

EMA releases details of restructuring.

FDA Reissues Bioanalytical Method Validation Guidance

September 12, 2013

FDA updates guidance to reflect advances in technology.

The Elements of Training

September 1, 2013

Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.

Europe Calls for Guarantee of GMP Standards

July 2, 2013

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

EU Battles Medicine Shortages

July 1, 2013

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.

FDA Urges Greater Focus on Contractor Quality

July 1, 2013

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.

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