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September 04, 2013
Prequalification of Sanofi Pasteur?s Menomune vaccine makes it eligible for purchase by United Nations agencies.
September 02, 2013
New FDA supply chain policies aim to strengthen inspection and oversight processes.
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
August 28, 2013
FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.
Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.
August 14, 2013
CDER withdraws some outdated guidance documents and makes plans to finalize others.
August 07, 2013
The guidance describes a risk-based approach to monitoring of clinical trials.
July 02, 2013
Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.
June 26, 2013
Cocrystals can enable the formulation of solid dosage drugs, but the FDA's final guidelines have left concerns about how their use could impact development timelines, the drug product manufacturing process, and the intellectual property position of products containing cocrystals.
June 12, 2013
ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages.