OR WAIT null SECS
August 09, 2016
The three-year report emphasizes the roll of collaboration in drug safety.
August 04, 2016
The report addressed how the agency might support medicine development for patients’ unmet medical needs.
The agency launched a public consultation on the revised guidance for new medicines to treat tuberculosis.
August 01, 2016
The pharmaceutical industry now braces itself for the consequences and complexities that could follow in the wake of the United Kingdom’s decision to leave the European Union.
July 22, 2016
The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.
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.