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Subtle Medical Imaging Software Cleared

[ Price : $8.95]

FDA clears a Subtle Medical 510(k) to market SubtleMR, an artificial intelligence image processing software.

Novens Schizophrenia Transdermal Patch Approved

[ Price : $8.95]

FDA approves a Noven Pharmaceuticals NDA for Secuado (asenapine) transdermal system for treating adults with schizophrenia.

FDA Pushed to Release Company Application Data

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NPR reports that transparency advocates are pushing FDA to release to the public more data from drug and medical device applicatio...

CGMP Violations at Indias Torrent Pharmaceuticals

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FDA warns Indias Torrent Pharmaceuticals about CGMP violations in its production of finished pharmaceuticals.

Glenmark Pharmaceuticals CGMP Violations

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FDA warns Indias Glenmark Pharmaceuticals about a CGMP violation in its production of finished pharmaceuticals.

Inactive Ingredient Database Suggestions

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Three stakeholders suggest changes to an FDA draft guidance on the inactive ingredient database.

Meeting Transcript on Cybersecurity Patient Messaging

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

Latest FDA Warning Letters

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

Akorn Betamethasone Dipropionate Lotion Approved

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

QS Violations at Denterprise International

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FDA warns Denterprise International about Quality System and Radiological Health violations in its work as a specification develop...