OR WAIT null SECS
July 22, 2016
The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.
The agency has recommended granting marketing authorization in the EU for Truvada.
July 12, 2016
The agency reviews hemophilia A, skin, and diabetes treatments, among others.
The agency completes its risk assessment of the blood cancer treatments.
July 02, 2016
Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.
June 27, 2016
ICH detailed the highlights of the council’s June 2016 meeting.
June 24, 2016
The agency is following up on a February 2016 inspection of the facility that found GMP violations.
The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.
The agency has suspended recommendation of Riluzole Alkem due to flawed study results.
June 23, 2016
China’s State Council issued a notice authorizing a trial plan for a new drug marketing authorization holder system for 10 provinces.