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August 06, 2013
A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.
July 02, 2013
Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.
European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.
June 11, 2013
EMA's revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.
May 08, 2013
EMA streamlines orphan drug application procedure.
March 02, 2013
FDA's requirements for API manufacturers in regards to ICH Q7.
February 19, 2013
The European Medicines Agency?s Committee for Orphan Medicinal Products (COMP) is seeking to expand its international cooperation in 2013.
February 02, 2013
Siegfried Schmitt, a principal consultant with PAREXEL, discusses how the EU's Falsified Medicines Directive will affect US API production.
January 01, 2013
The EU fine-tunes legislation for the Falsified Medicines Directive, which is due to take effect this month as part of efforts to better protect patients from counterfeits.
Siegfried Schmitt, a principal consultant with PAREXEL, discusses the EMA's guideline on process validation and how it compares with FDA's process validaton guidance.