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CGMP Violations in Tentamus India Inspection

[ Price : $8.95]

FDA warns Indias Tentamus India Private Limited contract laboratory about significant violations of CGMP regulations.

Advita Ortho Hit with 7 QS Violations

[ Price : $8.95]

FDA warns Exactech, doing business as Advita Ortho, about Quality System violations in its production of accessories for the Equin...

Rosemont Pharma Gets Complete Response on Valacyclovir

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FDA posts a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the companys NDA for valacyclovir.

Sen. Johnson Probing FDA Rare Disease Denials

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Senator Ron Johnson (R-WI) launches a congressional investigation into FDAs recent decisions to reject or delay treatments for rar...

FDA Opens New, Searchable Adverse Event Platform

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FDA launches its new Adverse Event Monitoring System to ultimately house all adverse events reported on FDA-regulated products on ...

FDA OKs Bristol Myers Squibbs Sotyktu for Psoriatic Arthritis

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FDA approves Bristol Myers Squibs Sotyktu (deucravacitinib), an oral therapy for treating adults with active psoriatic arthritis.

4 Major Issues Plaguing FDA: Newsweek

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A Newsweek report details four major issues it says have plagued FDA in its first year under commissioner Marty Makary.

CGMP Issues at Simtra BioPharma Solutions

[ Price : $8.95]

FDA warns Westphalia, Germany-based Simtra BioPharma Solutions about CGMP violations in its manufacturing of finished drugs.

Novo Nordisk PADE Reporting Violations

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FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug experience reporting requirements.

CGMP Violations at Fareva Morton Grove

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FDA warns Frances Fareva about CGMP violations in the production of finished drugs at its Morton Grove, IL, manufacturing facility...