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Panel Backs Sage Postpartum Depression Drug

[ Price : $8.95]

A joint FDA panel meeting votes 17 to 1 that data support the benefit-risk profile of Sages Zulresso (brexanolone) injection for t...

510(k) for Shoulder Arthroplasty Cleared

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FDA clears a Shoulder Innovations 510(k) for the InSet Humeral Short Stem System for partial or total shoulder arthroplasty used i...

Safety Alert on Potential Label Problems with EpiPen

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FDA issues a safety alert about labels attached to some Pfizer/Mylan EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, which may b...

Aquestive Therapeutics NDA for Seizure Drug Approved

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FDA approves an Aquestive Therapeutics NDA for Sympazan (clobazam) oral film for the adjunctive treatment of seizures associated w...

Advisory Panel Votes Down Alkermes Depression Drug

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Members of the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee vote 21 to ...

Guide on Unique Device ID Compliance Date Deferrments

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FDA posts a guidance on Unique Device Identification (UDI): Policy Regarding Compliance Dates for Class I and Unclassified Devices...

Draft Guide on Hepatitis B Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Chronic Hepatitis B Virus Infection: Developing Drugs for T...

Workshop on Hemophilia Product Development

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Federal Register notice: FDA announces a 12/6 public workshop entitled Product Development in Hemophilia.

FDA Approves Controversial Pain Drug

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FDA approves an AcelRx Pharmaceuticals resubmitted NDA for Dsuvia (sufentanil sublingual tablet, 30 micrograms) for treating moder...

2 Devices Cleared for Parathyroid Tissue Detection

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FDA permits the de novo marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures ...