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FDA Will Meet with Petros on Stendra Labeling

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FDA will meet with Petros over proposed labeling changes for the companys Stendra erectile dysfunction medicine.

FDA Approves Sol-Gels Twyneo Acne Treatment

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FDA approves Sol-Gel Technologies acne medication Twyneo that uses a patented technology to stabilize one of the active ingredient...

Evren Breakthrough on Earbud PTSD Therapy

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FDA grants Evren Technologies a breakthrough device designation for its Phoenix earbud device and its use in treating post-traumat...

Incyte BLA for Retifanlimab Turned Down by FDA

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FDA issues Incyte a complete response letter on its BLA for retifanlimab, an intravenous PD-1 inhibitor for treating certain adult...

Cell Tissue Panel to Discuss Toxicity Risks

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Federal Register notice: FDA announces a 9/2-3 Cellular, Tissue and Gene Therapies Advisory Committee meeting.

Gloves Remain Class 1; 510(k) Required

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Federal Register notice: FDA rescinds a 1/15 notice that identified seven types of reserved Class 1 devices that HHS had determine...

FDA Complete Response on Iterum NDA

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FDA issues Iterum Therapeutics a complete response letter on its NDA for sulopenem etzadroxil/probenecid, indicated for treating t...

Comments Extended on Powered Patient Transport

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Federal Register notice: FDA extends the comment period for a 6/15 notice on: Exemption from Premarket Notification: Powered Patie...

Patient Advocates Sought for FDA Collaboration

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Federal Register notice: FDA and the Clinical Trials Transformation Initiative request applications for patient advocates interest...

MAPP on ANDA Labeling Changes

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FDA revises a Manual of Policies and Procedures (MAPP) entitled Generic Drug Labeling Revisions Under Section 505(j)(10) of the Fe...