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FDA Hits Lupin with 5-item Form 483

[ Price : $8.95]

FDA issues Lupin a five-item Form 483 after an inspection at the firms Madhya Pradesh, India manufacturing plant cited significant...

FDA Clears NinePoint Real-time Image Segmentation

[ Price : $8.95]

FDA clears a NinePoint Medical 510(k) to market its Intelligent Real-time Image Segmentation software upgrade for its NvisionVLE I...

FDA Guide on Device UDI Compliance Dates

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Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Policy Regarding Compliance Dates f...

Info Collection Extension for Biosimilar User Fees

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension for Biosimilars User Fee Program.

Panel Backs Sage Postpartum Depression Drug

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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...