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Drug User Fee Program Fee Invoices Mailed

[ Price : $8.95]

CDER says FY 2019 User Fee Program Fee invoices were emailed 8/15 with a 10/1 due date for the $309,915 fee.

Improper Influence on FDA Science, Survey Says

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A Center for Science and Democracy survey of FDA scientists praises agency leaders while raising some concerns about political and...

Evoke Pharma NDA for Diabetic Gastroparesis Therapy

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FDA accepts for review an Evoke Pharma 505(b)(2) NDA for Gimoti, a nasal spray product candidate for relieving symptoms in adult w...

Sun Pharma Tear Production Drug Approved

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FDA approves Sun Pharmaceutical Industries Cequa (cyclosporine ophthalmic solution) 0.09%, indicated to increase tear production i...

Endo Drug Compounding Suit Moving Forward

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Endo resumes its suit challenging FDAs interim policy on drug compounding and seeking removal of vasopressin from Category 1 nomin...

FDA Approves Eisai and Mercks Lenvima

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FDA approves Eisai and Mercks kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hep...

Changes Sought in LPAD Draft Guidance

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Two pharmaceutical trade associations suggest changes to a draft antibiotic limited population pathway guidance.

Priority Preview Voucher Granted to Ultragenyx

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Federal Register notice: FDA issued a priority review voucher to Ultragenyx Pharmaceutical for its approved rare pediatric disease...

Info Collection Extension on Adverse Event Guide

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Federal Register notice: FDA seeks comments on an information collection extension entitled Guidance for Industry on Postmarketing...

Support, Questions on Antibiotic Pathway Guidance

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Four stakeholders comment to FDA on the agencys draft of a limited population pathway for antibacterial and antifungal drugs.