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FDA updates a guidance entitled Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Se...[ Price : $8.95]
FDA faces another Covid-19 debacle as it deals with over 1,300 Chinese firms providing medical protective equipment that registere...[ Price : $8.95]
FDA approves the expansion of a USGI Medical pilot study of it obesity-treating endoscopic procedure known as POSE 2.0.[ Price : $8.95]
Mylan says it is urging FDA to speed up its review of the companys ANDA for a generic copy of Biogens multiple sclerosis (MS) drug...[ Price : $8.95]
FDA posts a guidance entitled Good Manufacturing Practice Considerations for Responding to Covid-19 Infection in Employees in Drug...[ Price : $8.95]
Federal Register notice: FDA announces a 7/14 online/teleconferencing Oncologic Drugs Advisory Committee meeting that will review ...[ Price : $8.95]
Federal Register notice: FDA corrects a 2/12/2019 notice that announced the withdrawal of approval of 12 ANDAs from multiple appli...[ Price : $8.95]
FDA approves a 300 mg single-dose pre-filled pen for Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab).