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Stakeholder Suggestions for IHC Q5A Guidance

[ Price : $8.95]

Two pharmaceutical associations suggest ways to clarify an International Council on Harmonization draft guidance on evaluating the...

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Ofirmev Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Mallinckrodts Ofirmev (acetaminophen) injection, 1,000 mg/100 ml, was not withdrawn f...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

[ Price : $8.95]

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

[ Price : $8.95]

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

Liver Disease Prognostic Tests Put in Class 2

[ Price : $8.95]

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

[ Price : $8.95]

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

BsUFA 3 Changes Described

[ Price : $8.95]

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

Woman Sentenced in Drug Trial False Statement Case

[ Price : $8.95]

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

[ Price : $8.95]

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