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Panel to Discuss Enteromedics PMA for Obesity

04/21/2014

Eyelid Weight into Class 2

04/21/2014

Comments Sought on Customer Service Surveys

04/17/2014

Federal Register Notice: FDA is seeking public comment on voluntary customer satisfaction service surveys to implement Executive O...

FDA Issues Emergency Use for Influenza A (H7N9)

04/17/2014

Federal Register Notice: FDA is issuing an Emergency Use Authorization (EUA) for an in vitro diagnostic device for detecting the n...

Guidance on IDE Clinical Trials

04/17/2014

Federal Register Notice: FDA is making available a draft guidance entitled Live Case Presentations During Investigational Device E...

Guidance on Ophthalmic Devices

04/17/2014

Federal Register Notice: FDA is making available a draft guidance entitled Endotoxin Testing Recommendations for Single-Use Intrao...

Comments Sought on Orphan Drug Product Form

04/16/2014

Federal Register Notice: FDA is seeking public comment on the proposed collection of certain information on Orphan Drug Products: ...

FDA Reschedules Workshop on Pediatric Bone Health

04/16/2014

Federal Register Notice: FDA’s Pediatric and Maternal Health Staff in CDER and the Office of Pediatric Therapeutics are resc...

Workshop on Health IT Technology

04/16/2014

Federal Register Notice: FDA will hold a public workshop 5/13-15 entitled “Proposed Strategy and Recommendations for a Risk-...

Drug Benefit-Risk Workshop Rescheduled

04/16/2014

Federal Register Notice: FDA is rescheduling a 2/13 public workshop convened by the Institute of Medicine entitled “Characte...