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In what seems to be part of the lead up to the departure of the UK from the European Union, the European Medicines Agency laid out how sponsors holding orphan drug designations should go about transferring their EMA registrations from one country to another. Read More
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 of the fiscal year before. Read More
The FDA is using President Trump’s mandate to shrink the size of the government’s regulatory footprint as an opportunity to re-examine how its rules may be misused to delay generic competition — and to clear the decks of older regulations that advances in science have made obsolete, a senior HHS official told lawmakers Tuesday. Read More