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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
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
The European Medicines Agency and the European Network for Health Technology Assessment released a joint work plan to help medicine developers improve clinical research and become more efficient in generating the evidence needed for both agencies. Read More
The European Commission formally adopted updated regulations on good manufacturing practices for pharmaceuticals generally and for investigational drugs and clinical trials more specifically. Read More
The FDA’s draft guidance on post-approval manufacturing changes for biological products needs work to clarify how it fits with previous agency documents, according to written comments on the draft. Read More