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Injectable Cetirizine Approved for Acute Urticaria

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FDA approves a TerSera Therapeutics NDA for Quzyttir (cetirizine hydrochloride) injection for treating acute urticaria in adults a...

Safety Alert on Efficient Labs Cough Syrups

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FDA issues a safety alert on Efficient Laboratories Rompe Pecho EX and Rompe Pecho CF cough syrups due to microbial contamination ...

Info Collection Extension on Tobacco Form

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Federal Register notice: FDA seeks comments on an information collection extension entitled Potential Tobacco Product Violations R...

Mortality Concerns Cloud Shionogis Cefiderocol: FDA

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FDA drug reviewers raise mortality concerns with a Shionogi urinary infection NDA for cefiderocol injection that heads to an advis...

Subtle Medical Imaging Software Cleared

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

Novens Schizophrenia Transdermal Patch Approved

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Three stakeholders suggest changes to an FDA draft guidance on the inactive ingredient database.