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Palacio Debarred Over FDA False Statements

[ Price : $8.95]

Federal Register notice: FDA permanently debars Jessica Palacio from providing services to any person that has approved or pending...

Respironics Recalls OmniLab Ventilator

[ Price : $8.95]

Philips Respironics recalls (Class 1) its OmniLab Advanced + Ventilator because the device may experience an interruption or loss ...

Panel Backs Shield Colon Cancer Test

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An FDA advisory committee recommends the approval of a Guardant Health PMA for the Shield blood test for colorectal cancer screeni...

Hospira Recalls Buprenorphine and Laberalol Lots

[ Price : $8.95]

Pfizers Hospira drug unit recalls (Class 1) several lots of buprenorphine HCl injection Carpuject units and labetalol HCl injectio...

Laurus Labs Cited on GMPs in India

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FDA cites Laurus Labs (Hyderabad, India) over GMP deficiencies following a 12/2023 inspection at the firms active pharmaceutical i...

FDA Denies Ipsen Somatuline Depot Petition

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FDA denies all five Ipsen Pharmaceuticals requests for agency actions on ANDAs for a generic form of Ipsens Somatuline Depot.

8 New GDUFA Research Grants in FY 2023: Report

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The FY 2023 GDUFA Science and Research Report examines GDUFA-funded research in eight priority areas affecting generic drug develo...

FDA Seeks Mandatory Drug Recall, Other Powers

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CDER, CBER, and CDRH directors tell Congress they need additional legal authorities to be able to continue to provide the services...

Fast Track Granted for Pancreatic Cancer Drug

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FDA grants Theriva Biologics a fast-track designation for its lead clinical candidate VCN-01 in combination with gemcitabine and n...

PhRMAs 4 Open FDARA Implementation Issues

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Pharmaceutical Research and Manufacturers of America asks FDA to address four issues relating to implementation of the FDA Reautho...