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August 04, 2016
A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.
FDA approved Natco and Alvogen’s generic Tamiflu to treat and prevent influenza.
August 02, 2016
Regulators and manufacturers address economic and ethical issues for scarce medicines.
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 27, 2016
FDA and industry seek speedy Congressional approval of new user fee plan.
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 20, 2016
The committee voted unanimously in favor of approving the drug, but the majority supported implementing additional risk management.
July 19, 2016
FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.