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Federal Register

Panel to Review Isotretinoin REMS Changes

Federal Register notice: FDA announces a 3/28-29 a joint advisory committee meeting to discuss proposed changes to the isotretinoin iPLEDGE Risk Evalu...

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Human Drugs

Stakeholder Suggestions for IHC Q5A Guidance

Two pharmaceutical associations suggest ways to clarify an International Council on Harmonization draft guidance on evaluating the viral safety of bio...

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Federal Register

FDA Permanently Debars Product Testing Lab Owner

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

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Federal Register

Ofirmev Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Mallinckrodts Ofirmev (acetaminophen) injection, 1,000 mg/100 ml, was not withdrawn for safety or effecti...

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Human Drugs

FDA Denies Petition on Gabapentin Scheduling

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

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Human Drugs

Merck Fixing Nitrosamine Formation in Januvia Batches

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

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EIRS/483s

Liver Disease Prognostic Tests Put in Class 2

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

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FDA General

Improve FDA Management of IT Contracts: OIG

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

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Human Drugs

BsUFA 3 Changes Described

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

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Human Drugs

Woman Sentenced in Drug Trial False Statement Case

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