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8 New GDUFA Research Grants in FY 2023: Report

[ Price : $8.95]

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...

Vyaire Medical Recall Twin Tube Lines

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Vyaire Medical recalls (Class 1) its Twin Tube sample lines, which are used on the Vyntus CPX Cardiopulmonary Exercise Test, due t...

Draft Guide on Vet Drug Residues

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Federal Register notice: FDA makes available a draft revised guidance entitled Studies to Evaluate the Safety of Residues of Veter...

IDE for Brain Interchange Implant in Stroke Therapy

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FDA approves a CorTec IDE to allow the University of Washington School of Medicine to conduct a study involving the closed-loop Br...

Evaluating Immunosuppressive Effects in Drugs Workshop

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Federal Register notice: FDA announces a 7/11 public workshop entitled Evaluating Immunosuppressive Effects of In Utero Exposure t...

Comments Extended on Animal Drug Labeling Rule

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Federal Register notice: FDA extends the comment period on its proposed rule entitled Labeling Requirements for Approved or Condit...

Otsuka Scraps Alzheimers Agitation Drug

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Based on disappointing Phase 3 trial data, Otsuka Pharmaceutical terminates its development of the novel compound AVP-786 as a pot...