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HHS Should Reverse LDT Policy: House Committee

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The House Energy and Commerce Committee asks HHS to reverse the Trump administration's decision to remove FDA authority to require...

Hearing on BioSolutions Covid Vaccine Troubles

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The House Select Subcommittee on the Coronavirus Crisis announces a hearing that will take testimony next week from two Emergent B...

New FDA Head Should Push Trial Transparency: Op-Ed

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Two law students and a professor say whoever becomes FDA commissioner should commit to enforcing clinical trial transparency.

FDA Alert on Pacemaker Interference Caused by Cell Phone

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FDA advises pacemaker and other electronic implant device wearers to keep their cell phones, smart watches and other electronic de...

After 2 Rejections, Heron Pain NDA Finally Approved

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FDA approves a Heron Therapeutics NDA for Zynrelef (bupivacaine and meloxicam) extended-release solution for use in adults for sof...

Abbott Recall of 2 Pacemaker Models is Class 1

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FDA says an Abbott recall of some Endurity and Assurity bradycardia pacemakers is Class 1.

FDA May Be Too Reliant on User Fees: Professor

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University of Connecticut pharmacy professor C. Michael White says FDA may be too dependent on user fees and needs more taxpayer f...

Strongbridge NDA for Cushings Syndrome

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FDA accepts for review a Strongbridge Biopharma NDA for Recorlev (levoketoconazole) for treating endogenous Cushing's syndrome.

Guide on Drug Biopharmaceutics Classification

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Federal Register notice: FDA makes available a final guidance entitled M9 Biopharmaceutics Classification System-Based Biowaivers.

1st Office of Surveillance and Epidemiology Annual Report

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The CDER Office of Surveillance and Epidemiology issues its first annual report dealing with four core functions and looking to th...