FDA Eyes Nanotech Standards Process With More Unknown Than Known

FDA acknowledges the impact nanotechnology is making in food, dietary supplement and cosmetic products, but likely is years away from proposing regulations for its use, says Norris Alderson, the agency's associate commissioner for science

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EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
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Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.