OR WAIT null SECS
October 23, 2015
The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards
September 28, 2015
The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.
September 01, 2015
The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.
July 27, 2015
EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.
July 16, 2015
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
July 13, 2015
The European Medicines Agency reviews the safety of human papillomavirus vaccines.
The International Conference on Harmonization has moved ICH M7(R1) Addendum to 3 of the ICH process.
June 16, 2015
The agency creates initiative to stimulate pediatric drug development.
May 02, 2015
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.
April 24, 2015
The agency has recommended granting marketing authorization for Opdivo.