"The 2000 FDA Science Forum - FDA and the Science of Safety: New Perspectives" will explore scientific and practical issues related to safety evaluation and risk management of FDA-regulated products. The program, scheduled for Feb. 14-15 at the Washington Convention Center in D.C., will bring FDA scientists together with industry, academia, government agencies, consumer groups and the public. Topics slated for discussion include post-market surveillance and the Food Safety Initiative. The meeting is co-sponsored by FDA's Office of Science, the American Association of Pharmaceutical Scientists, FDA's Office of Women's Health and the agency's chapter of Sigma Xi, a scientific research society
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
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.
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.
