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Marmas Debarred From Personal Drug Importation

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Federal Register notice: FDA debars for five years Brenda K. Marmas from personally importing any drug into the U.S.

Axsome Therapeutics Gets FDA Inspection Confirmation

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FDA tells Axsome Therapeutics that it will meet its inspection deadline on inspecting the companys contract manufacturing facility...

Non-Opioid Analgesic Draft Guidance

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FDA publishes a draft guidance on the development of non-opioid analgesics for acute pain.

Finalize Hearing Aid Rule Now: Senators

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Eleven senators urge FDA to finalize its over-the-counter hearing aid rule quickly now that the public comment period has ended.

Stakeholders Comment on Rhinosinusitis Draft

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Three stakeholders comment on an FDA draft guidance on developing drugs to treat rhinosinusitis with nasal polyps.

AdvaMed Comments on FDA 3D Printing Paper

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AdvaMed says FDA should make changes to a discussion paper on 3D printing of medical devices at the point of care to explicitly in...

Gamida Cell Begins BLA for Omidubicel

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Gamida Cell initiates a rolling BLA submission for omidubicel, indicated for patients with blood cancers in need of stem cell tran...

FDA Approves Celexa Safety Labeling Changes

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FDA approves safety-related labeling changes for Allergans anti-depressant drug Celexa.

OMB Completes Review of Harmonized QSR Proposed Rule

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The White House Office of Management and Budget completes its review of CDRHs long-awaited proposed rule to modernize the medical ...

Allergan Gains Juvederm Undereye Approval

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FDA approves Allergan Aesthetics Juvderm Volbella XC for an additional indication improving infraorbital (undereye) hollows in ad...