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Early Alert on Baxter Volara Breathing Device Circuits

[ Price : $8.95]

FDA issues an early alert regarding a potentially high-risk issue affecting certain patient circuits used with Baxter's Volara Sys...

FDA Authorizes 1st Generic Animal Drug for New World Screwworm

[ Price : $8.95]

FDA authorizes Felix Pharmaceuticals generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats.

FDA Issues 2nd Complete Response Letter on Acromegaly Drug

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FDA sends a second complete response letter to Camurus regarding its NDA for Oclaiz (octreotide), an extended-release injection un...

Doctor, Staff Charged with Falsifying Trial Data

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The Department of Justice says a federal grand jury has indicted the co-owner of Floridas Pine Care Research Center and two staff ...

Kidney Risk in OTC Weight Loss Drug Alli

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FDA approves labeling changes for Haleons OTC weight loss drug alli to warn of the rare risk of kidney injury associated with its ...

Fewer But Longer Drug Shortages: USP Report

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The United States Pharmacopoeia 2025 annual drug shortage report documents a reduction in the number of drug shortages but an incr...

Require In Vivo BE Test for Tafinlar ANDA: Petition

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A Windels Marx petition asks FDA not to approve any ANDA for dabrafenib mesylate using the 505(j)(2)(C) pathway that doesnt includ...

Plausibility Mechanism Guidance Needs Clarifications: Article

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A Health Affairs article discusses clarifications and revisions that it says are needed in an FDA draft guidance describing a plau...

Changes in HCEI Draft Guidance Noted

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Three Akin Gump attorneys highlight some changes in a 2026 FDA draft guidance on communicating healthcare economic information fro...

Comments Extended and Workshop Planned for Drug Repurposing

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FDA extends the comment period by 30 days for its request for information on drug repurposing for unmet medical needs.