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Panel to Discuss Superion InterSpinous Spacer


Federal Register Notice: FDA’s Orthopedic and Rehabilitation Panel of the Medical Devices Advisory Committee will meet 2/20,...

Detroit Conference on Transforming FDA Policy


Federal Register Notice: FDA, Detroit District Office and the Association of Food and Drug Officials will co-sponsor a public conf...

CBER Seeks Participants for Site Visit Program


Federal Register Notice: CBER is inviting participants for its Regulatory Site Visit Training Program. It is intended to give CBER...

CDER Seeks Sites Tours Program Participants


Federal Register Notice: CDER is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Intera...

Info on Export Certificates Sent to OMB


Federal Register Notice: FDA’s proposed collection of information, “Export of Food and Drug Administration Regulated P...

Panel to Discuss Organon NDA for Neuromuscular Blockade


Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet 3/18, from 8 a.m. to 5 p....

Comments Sought on Generic Drug User Fees


Federal Register Notice: FDA is reopening a docket to solicit public comment on certain topics related to implementation of the Ge...

FDA Proposes Regs on 505(b)(2)/ANDAs


Federal Register Proposed rule: FDA is proposing regulations to implement Title XI of the Medicare Prescription Drug, Improvement,...

Panels to Discuss Avedro NDA For Ophthalmic Conditions


Federal Register Notice: FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medi...

Info on Animal Extrabel Drug Use Sent to OMB


Federal Register Notice: FDA’s proposed collection of information, “Extralabel Drug Use in Animals — 21 CFR 530,...