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Multiple Serious Violations at LifeHealth Science

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FDA warns LifeHealth Science that its OR product is considered to be an unapproved and misbranded new drug and also violates dieta...

Process for Publishing Covid-19 EUAs

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Federal Register notice: FDA announces its process for publishing FDA Emergency Use Authorizations for medical devices related to ...

FDA Acts to Increase Sanitizer Supply, Control Carcinogens

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FDA publishes interim levels of certain ethanol impurities that would be acceptable in hand sanitizers during the Covid-19 public ...

Amneal Recalls All Metformin Lots

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Amneal recalls all lots of metformin HCl extended-release tablets after FDA analysis finds unacceptable levels of NDMA.

Drug Industry Lobbies Against Affordable Covid Meds: Analysis

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Public Citizen says many organizations opposing plans to make Covid-19 treatments and vaccines affordable have received drug indus...

FDA Must Apply Rigorous Standards to Covid Vaccine: Column

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Two University of Pennsylvania medical school professors urge FDA to resist any efforts to rush an authorization for any Covid-19 ...

Covid-19 Hurts FDA Foreign Drug Inspections: GAO

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A Government Accountability Office official tells the Senate Finance Committee that the Covid-19 public health emergency is exacer...

Y-mAbs Files BLA for Neuroblastoma

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FDA accepts for review a Y-mAbs Therapeutics BLA for Danyelza (naxitamab) for treating patients with relapsed/refractory high-risk...

Oncology Panel to Reviw 4 Pediatric Study Plans

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Federal Register notice: FDA announces a 6/17-18 Oncologic Drugs Advisory Committee meeting that will review four pediatric develo...

Guide on IRB Reviews of Expanded Access Requests

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FDA posts a guidance on institutional review board reviews of individual patient expanded access requests.