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Info Collection on Custom Devices

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Federal Register notice: FDA seeks comments on an information collection extension entitled Custom Devices (OMB Control Number 091...

Acadia Drug for Rett Syndrome Approved

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FDA approves an Acadia Pharmaceuticals NDA for Daybue (trofinetide) oral solution for treating Rett syndrome.

FDA/CDC Correct Florida Officials Vaccine Misinformation

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FDA and CDC send a letter to Florida surgeon general Joseph Ladapo to correct his misinterpretations and misinformation about Covi...

Panel to Review Entasis Therapeutics NDA

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Federal Register notice: FDA announces a 4/17 Antimicrobial Drugs Advisory Committee meeting to discuss an Entasis Therapeutics ND...

GAO Report Hits FDA on Advanced Manufacturing Tracking

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A new Government Accountability Office report recommends that FDA better track the extent of its efforts to encourage drug manufac...

FDA Outlines Disposition of Covid-19 Guidances

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FDA publishes a Federal Register notice outlining the status of the many guidance documents that were issued to address the Covid-...

FDA Divides into Two its Guide on Face Masks

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FDA splits into two its guidance entitled Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks,...

Pfizer NDA for Migraine Nasal Spray OKd

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FDA approves a Pfizer NDA for Zavzpret (zavegepant), the first calcitonin gene-related peptide receptor antagonist nasal spray for...

18 Senators Want End to Accelerated Approval Pricing Model

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A letter from 18 Republican senators urges HHS to abandon a Medicare pricing model that aims to balance incentives for developing ...

Baxter Device Correction for Life2000 Ventilator

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Baxter International issues an urgent medical device correction for its Life2000 Ventilation System due to the potential for patie...