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Senators Introduce Bill to Curb FDA Oversight of Mobile Apps

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Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduce a bill to reduce red tape at FDA and boost innovation in health in...

Courts May Need to Help Generics Get Testing Samples: Lawyers

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A Wiley Rein client alert opines on a recent draft guidance offering generic drug sponsors one means to get testing samples from r...

Guidance on Safety of BE Study Protocols

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Federal Register Notice: FDA releases a draft guidance: entitled How to Obtain a Letter from FDA Stating that Bioequivalence Study...

FDA Withdraws 23 NDAs, 68 ANDAs

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Federal Register Notice: FDA withdraws approval of 23 NDAs and 68 ANDAs that are no longer marketed.

FDA Approves Wraser Pharm Trezix for Pain Usage

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FDA approves a Wraser Pharmaceuticals NDA for Trezix (acetaminophen/caffeine/dihydrocodeine bitartrate) capsules, indicated for pa...

Fewer FDA-483s Issued in FY 2014

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FDA issues fewer FDA-483s in fiscal year 2014 than last year, according to just-released inspection data.

Compounding Pharmacy Guilty Plea After Product Contamination

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Main Street Family Pharmacy (Newbern, TN) and co-owner David A. Newbaker plead guilty in Western Tennessee District Court to one m...

Atossa Genetics Resolves Inspection Deficiencies

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Atossa Genetics says it has received inspection close-out notifications for FDA inspections conducted in 2012 and 2014.

Brookings Drafts Roadmap for Device UDI Implementation

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A Brookings Institution report says FDA and the Centers for Medicare and Medicaid Services should run a health sector-wide pilot p...

Ebola Priority Review Voucher Bill Goes to House

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The Senate approves unanimously legislation adding Ebola as a qualifying disease for the FDA priority review voucher program.