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FDA Permanently Debars Product Testing Lab Owner

[ Price : $8.95]

Federal Register notice: FDA issues an order permanently debarring Gabriel J. Letizia, Jr from providing services related to an ap...

Ofirmev Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Mallinckrodts Ofirmev (acetaminophen) injection, 1,000 mg/100 ml, was not withdrawn f...

FDA Denies Petition on Gabapentin Scheduling

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FDA denies a citizen petition from advocacy group Public Citizen that urged it and the Drug Enforcement Administration to open pro...

Merck Fixing Nitrosamine Formation in Januvia Batches

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Merck says it has identified the root cause of nitrosamine formation in certain Januvia (sitagliptin) batches.

Liver Disease Prognostic Tests Put in Class 2

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Federal Register notice: FDA classifies prognostic tests for assessing liver-related disease progression into Class 2 (special con...

Improve FDA Management of IT Contracts: OIG

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The HHS Inspector General says FDA has concurred with recommendations on steps to improve its management of IT acquisition contrac...

BsUFA 3 Changes Described

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Two CDER officials describe work being done under the Biosimilar User Fee Amendments 3.

Woman Sentenced in Drug Trial False Statement Case

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A Florida woman is sentenced to three years in jail for submitting a false affidavit to an FDA investigator looking into issues wi...

Appeals Court Nixes Sandoz Generic Aubagio Suit

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The DC Circuit Court of Appeals says Sanofi was entitled to new chemical entity exclusivity for its Aubagio and Sandoz is not enti...

Negative Controls and Real-World Evidence Workshop

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FDA announces a 3/8 workshop entitled Understanding the Use of Negative Controls to Assess the Validity of Non-Interventional Stud...