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Microneedling Device Guidance Out

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FDA releases a draft guidance to help industry know when a microneedling product is legally considered a medical device subject to...

Drug/Biologic User Fees for FY 2018

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Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2018.

Biosimilar User Fee Rates for FY 2018

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Federal Register notice: FDA announces rates for biosimilar user fees for fiscal year 2018.

FDA Accelerated Approval for Bayer Kinase Inhibitor

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FDA grants accelerated approval to Bayer Healthcare Pharmaceuticals Aliqopa (copanlisib) for treating adults with relapsed follicu...

Organ Preservation Device Guidance Out

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FDA issues a draft guidance on its current thoughts on how animal transplant models can be used to evaluate organ preservation tec...

FDA is Being Flexible in Fast Track Approvals: Post

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Hyman, Phelps & McNamara attorneys say that since 2015 FDA has been demonstrating flexibility leading to increased fast track appr...

Draft Guide on Microdose Radiopharmaceutical Diagnostic Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical...

Medtronic Recalls Infusion Sets Due to Defective Component

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Medtronic recalls several lots of infusion sets used with all models of Medtronic insulin pumps due to a defective vent membrane.

3 Charged in Fake Prescription Drug Lab Case

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The FDA Office of Criminal Investigations says three Florida residents have been charged in connection with importing, manufacturi...

FDA Accepts Astellas sNDA for Overactive Bladder Drug Combo

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FDA accepts for review an Astellas Pharma supplemental NDA that seeks approval for the use of mirabegron in combination with solif...