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Teva Recalls Combo Products for High Blood Pressure

[ Price : $8.95]

Teva Pharmaceuticals recalls all lots of amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide com...

Former Insys VP Pleads Guilty to Racketeering

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The Justice Department says the former Insys Therapeutics vice president for sales pleaded guilty to one count of racketeering con...

Astellas Xospata Approved for Acute Myeloid Leukemia

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FDA approves Astellas Pharmas Xospata (gilteritinib) tablets for treating adult patients who have relapsed or refractory acute mye...

6 Months Pediatric Exclusivity for Lyrica

[ Price : $8.95]

FDA grants six-month pediatric exclusivity to Pfizers Lyrica based on its use in pediatric epilepsy studies.

Dual 510(k), CLIA Waiver Application Guidance

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FDA issues a draft guidance to assist manufacturers in using the Dual 510(k) and CLIA Waiver by Application pathway.

User Fee Meeting on eSubmission Data Standards

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Federal Register notice: FDA announces a 4/10/2019 public meeting entitled Prescription Drug User Fee Act of 2017; Electronic Subm...

Restrictions Sought on Zelnorm sNDA

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Hyman, Phelps & McNamara asks FDA not to approve a Zelnorm sNDA without substantial evidence of safety and efficacy under currentl...

Synaptive Medical Recalls BrightMatter Guide

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Synaptive Medical recalls its BrightMatter Guide with SurfaceTrace Registration due to a software defect that could potentially re...

4 New ICH Groups Moving Ahead

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The International Council for Harmonization approves concept papers and business plans for three new informal working groups and a...

Mesa Biotechs Accula RSV Test Cleared

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FDA clears a Mesa Biotech 510(k) for its Accula RSV test, a respiratory syncytial test cassette for diagnosing both children and a...