Regulation and Compliance - BioPharm International

ADVERTISEMENT

Regulation and Compliance

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.

Thermal Protection for Control-Room-Temperature Products

November 1, 2013

The authors discuss how to develop a cost-effective thermally protective packaging system.

FDA Releases Report on Personalized Medicine

November 1, 2013

A new report details FDA's role and responsibilities in personalized medicine.

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.

ADVERTISEMENT

ADVERTISEMENT

Click here