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Medical Devices

Meeting Transcript on Cybersecurity Patient Messaging

FDA makes available a transcript of a 9/10 Patient Engagement Advisory Committee that recommended the agency develop standards for device companies to...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Glenmark Pharmaceuticals, Torrent Pharmaceuticals, Coral Pharmaceuticals and Denterpris...

Human Drugs

Akorn Betamethasone Dipropionate Lotion Approved

FDA approves an Akorn ANDA for betamethasone dipropionate lotion USP, 0.05%, a corticosteroid indicated for relieving inflammatory and pruritic manife...

Medical Devices

QS Violations at Denterprise International

FDA warns Denterprise International about Quality System and Radiological Health violations in its work as a specification developer, manufacturer of ...

Human Drugs

FDA Zantac Impurity Info Sheet Out

FDA says it does not have scientific evidence on which to base a recommendation to continue using or discontinue Zantac due to the presence of NDMA im...

Human Drugs

Understanding FDA Patient Experience Data Use

Sanofi researchers analyze FDA use of patient experience data in 2018 new molecular entity approvals to establish a baseline for further study.

Human Drugs

FDA extends Flexion sNDA Review for Zilretta

FDA extends the review of a Flexion Therapeutics supplemental NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension) that s...

Human Drugs

Study: Minimal FDA Policy Effects on ANDA Prices/Shortages

A new JAMA study finds minimal effects from FDAs recent policies to expand approvals for generic drugs at risk for price spikes and shortages.

Human Drugs

UCB Petition on Anti-epileptic Switching Rejected

FDA denies a 2006 citizen petition from UCB that sought labeling on all anti-epileptic drugs warning about drug switching patients who are seizure fre...

FDA General

FDA Dragged its Feet on Vaping for a Decade: NYT

A New York Times article examines FDAs alleged foot-dragging over the last decade that allowed e-cigarette use to explode to the detriment of teenager...