OR WAIT null SECS
July 02, 2013
European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.
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 11, 2013
EMA's revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.
FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico.
May 28, 2013
Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.
The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.
May 14, 2013
FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies.
May 08, 2013
EMA streamlines orphan drug application procedure.
May 02, 2013
The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.
April 23, 2013
FDA issues draft guidance to minimize medication errors.