Regulation and Compliance - BioPharm International

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Regulation and Compliance

Guideline Delineates How to Implement GS1 Standards to Support DSCSA

September 19, 2014

GS1 publishes a healthcare industry guideline describing how to implement GS1 standards to support requirements of the 2013 US Drug Supply Chain Security Act.

FDA Issues Warning Letter to API Manufacturer Apotex Pharmachem India

June 18, 2014

FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

FDA Issues Warning Letter to Tianjin Zhongan Pharmaceutical

June 18, 2014

FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

FDA Initiates Secure Supply Chain Pilot Program

February 18, 2014

Thirteen companies are accepted for participation in the supply chain program.

Clinical Trials Head East to Asia

December 1, 2013

The rising cost of drug development and the decreasing proportion of drug-naive population in the US and European markets are driving international pharmaceutical companies to consider emerging markets as a location to conduct their clinical trials. Asia stands out among the emerging markets given its double-digit growth rates.

Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability

December 1, 2013

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).

Challenges in Managing the Cold Chain

November 1, 2013

BioPharm International speaks with industry experts about challenges faced in managing the cold chain.

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 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.

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