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FDA Publishes 32 New Product-Specific Guidances

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FDA publishes 32 new and revised product-specific guidances to aid in development of generic drugs and a revised list of PSGs unde...

Breakthrough Status for Karius Test

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FDA grants Karius a breakthrough device designation for its Karius Test for use in the diagnosis and management of immunocompromis...

Clarify Animal Testing Rules: Humane Society

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The Humane Society of the U.S. petitions FDA to take actions to inform drug developers and sponsors that they are not always requi...

Group Urges $200 Million Boost in FDA Funding

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The Alliance for a Stronger FDA urges Congress to provide FDA with $3.9 billion in budget authority for fiscal year 2025, which is...

FDA Marks Office of Womens Health 30th Anniversary

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FDA commissioner Robert Califf and associate commissioner for womens health Kaveeta Vasisht tout successes of the agencys Office o...

Eisai Starts Rolling BLA for Leqembi Autoinjector

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Eisai opens a rolling BLA submission for an autoinjector to deliver maintenance doses of Leqembi in patients with early Alzheimers...

Change Pediatric Acetaminophen Directions: Petition

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Parenteral Technologies asks FDA to ban specific language from the directions for some liquid acetaminophen products indicated for...

Atraverses Hotwire Radiofrequency Guidewire Cleared

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FDA clears an Atraverse Medical 510(k0 for its Hotwire radiofrequency guidewire, a device that enables zero exchange left-heart ac...

Abbott Recalls HeartMate 3 Pump Over Leaks

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Abbott recalls (Class 1) its HeartMate 3 LVAS after reviewing complaints that identified blood or air leakages.

Acosta Debarred over Counterfeit Cough Syrup Scheme

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Federal Register notice: FDA issues an order permanently debarring Gina Acosta from providing services in any capacity to a person...