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PhRMA Concerns with Proprietary Name Study

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PhRMA says FDA should change a proposed survey on promotional implications of proprietary drug names if it intends to proceed with...

FDA OKs Herceptin Biosimilar Multi-dose Vial

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FDA approves a Samsung Bioepis supplemental BLA for a 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb), a biosimilar referen...

New Process for Virus Guidance Release

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Federal Register notice: FDA announces its process for making available guidance documents related to the coronavirus public healt...

Jazz NDA for Less Sodium Narcolepsy Drug

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FDA accepts for priority review a Jazz Pharmaceuticals NDA JZP-258 (oxybate), an investigational drug for treating cataplexy or ex...

Align Technology 5D Intraoral Scanner Cleared

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FDA clears an Align Technology 510(k) for the iTero Element 5D Imaging System.

Rescind Remdesivir Orphan Designation: Gilead

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Gilead asks FDA to rescind its orphan drug designation of the companys remdesivir as a potential treatment for Covid-19.

HCT/Ps Issues at California IVF Fertility Center

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FDA warns California IVF Fertility Clinic about significant deviations from HCT/Ps regulations.

Immediately-in-effect Guidance on Face Masks, Respirators

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FDA issues an immediately-in-effect guidance: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease-201...

Immediate Virus Guidance Issuance Policy

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Federal Register notice: FDA announces the process for making available FDA guidance documents related to the coronavirus outbreak...

April Blood Products Panel Postponed

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Federal Register notice: FDA postpones the 4/2-3 Blood Products Advisory Committee meeting.