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FDA Closes Out Warning Letters Sent to AngioDynamics

[ Price : $8.95]

FDA issues close-out letters to AngioDynamics involving Warning Letters in 2011 about its Queensbury, NY facility and in 2014 abou...

Warning Letters Sent to Picamilon Supplement Makers

[ Price : $8.95]

FDA sends five Warning Letters to manufacturers marketing dietary supplements containing picamilon as a dietary ingredient, asking...

FDA Accepts Medicure sNDA for Aggrastat

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FDA accepts for review a Medicure supplemental NDA for Aggrastat (tirofiban HCl) that seeks an expanded indication to include trea...

Guidance on Blood Donor Suitability in Ebola Outbreaks

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Federal Register Notice: FDA releases a draft guidance: Recommendations for Assessment of Blood Donor Suitability, Donor Deferral ...

CBE Rule Delay Risking Generic Drug Patients: Public Citizen

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Public Citizen calls on FDA to quickly finalize its proposed rule to allow generic drug manufacturers to update safety warnings wi...

FDA Panel Votes Down Depression Drug

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FDAs Psychopharmacologic Drugs Advisory Committee votes to not recommend approval for a Fabre-Kramer Pharmaceuticals NDA for gepir...

2nd Patient Dies in Zafgen Obesity Trial

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Zafgen says a second death has been reported in a Phase 3 trial of beloranib in patients with Prader-Willi syndrome.

Insulet Safety Alert on OmniPod Insulin Delivery

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FDA says Insulet Corp. has issued a lot-specific voluntary Field Safety Notification for 15 lots of its OmniPod insulin deliverty ...

Cellular Therapy Needs Regulatory Pathway: Report

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A Bipartisan Policy Center report calls on FDA to create a new regulatory pathway that would promote the use of cellular therapy i...

FDA January Workshop on Device Cybersecurity

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FDA announces a two-day (1/20-21/16) public workshop entitled Moving Forward: Collaborative Approaches to Medical Device Cybersecu...