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FDA issues a guidance for people who want to comment during advisory committee sessions.[ Price : $8.95]
Teva Pharmaceutical Industries says it could file an NDA late next year after reporting positive Phase 3 trials involving oral laq...[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Novartis Ilaris for the purpose of patent extension.[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Ube Industries Bepreve for the purpose of patent extensio...[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Lundbeck, Inc.s Sabril for the purpose of patent extensio...[ Price : $8.95]
Capping other quality failures this year, McNeil recalls all U.S. lots of three Rolaids products after consumers report finding wo...[ Price : $8.95]
CDER director Janet Woodcock tells an industry meeting that the agency needs to make the risk evaluation and mitigation strategy (...[ Price : $8.95]
The Presidents Council of Advisors on Science and Technology urges rapid decisions to establish a universal exchange language for ...