We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
In the first month of the GDUFA II program, the FDA sent 325 complete response letters to generics manufacturers — far more than the high of 190 seen in August the fiscal year before. Read More
The FDA is working to develop and finalize a handful of new guidances on bringing complex generics to market — including complicated medicines that may require alternate methods of establishing bioequivalence, as well as drug-device combination products that may be blocked by iterative patents. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended seven new products for European Commission approval, including one biosimilar and two orphan medicines, one being an advanced cell therapy. Read More
The FDA outlined how it will use information requests and the newly established discipline review letter — which originates from specialized staff concerning their portion of an ANDA review, such as bioequivalence, quality or labeling. Read More
The FDA continued to issue a larger number of complete response letters to generics manufacturers last month — dropping from a spike in October, but still higher than any single month in the previous fiscal year. Read More
The FDA should not approve generics of Glaxo Smith Kline’s asthma drug Advair Diskus that depend on multiple-batch studies to show pharmacokinetic bioequivalence, according to Mylan. Read More