FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
UniQure said the U.S. Food and Drug Administration no longer agreed that clinical data for the Dutch company's gene therapy for Huntington's disease may be adequate for a marketing application, ...
The director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, George Tidmarsh, resigned on Sunday amid serious concerns about his personal conduct, a Department of ...
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FDA’s top drug regulator resigns after federal officials probe ‘serious concerns’ about his conduct
The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government ...
The FDA's top drug regulator, Dr. George Tidmarsh, quit after federal officials began reviewing "serious concerns about his ...
Anil R. Diwan, PhD, President and Executive Chairman of the Company will provide an update on the Company, its Drug Pipeline ...
Dr. George Tidmarsh, the Food and Drug Administration’s top drug regulator, was placed on administrative leave and is ...
The New Jersey-based Ascend Laboratories recalled 140,000 tablets of Atorvastatin Calcium. Pharmacies sold the statin drug as ...
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