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Court Cuts Covid Vaccine FOIA Stay to 6 Months

[ Price : $8.95]

The DC federal court approves a six-month stay in FDAs records production for an FOIA request from Childrens Health Defense for re...

45% of CDER Warning Letters Cited GMPs: Report

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CDER says 45% of drug Warning Letters issued in fiscal year 2023 cited GMP requirement violations.

Guide on Biologic Viral Safety Evaluations

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Federal Register notice: FDA makes available a final guidance entitled Q5A(R2) Viral Safety Evaluation of Biotechnology Products D...

Darmiyan De Novo for Alzheimers Assessor

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FDA grants Darmiyan a de novo marketing authorization for its clinical test BrainSee for assessing Alzheimers dementia risk.

Fresenius Recalls Infusion Pump

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Fresenius Kabi recalls its Ivenix Large Volume Pump because some units have mechanical issues with the fluid valve pins in the dev...

Keytruda Approved for FIGO Cervical Cancer

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FDA approves Mercks Keytruda (pembrolizumab) with chemoradiotherapy (CRT) for treating patients with FIGO 2014 Stage III-IVA cervi...

Bill to Stockpile Pediatric Cancer Drugs

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Three Democrat U.S. Reps. introduce the Pediatric Cancer Drug Supply Act of 2024, legislation that is intended to ensure there is ...

FDA Needs More Supplement Authority: GAO

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The Government Accountability Office says its testing of prenatal dietary supplements found that many had more or less nutrients t...

Shorla NDA Accepted for Breast/Ovarian Cancer

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FDA accepts for review a Shorla Oncology NDA for SH-105 for treating breast and ovarian cancer.

Florida Drug Import Plan Non-Starter: Canada

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Canadian officials say they will act to prevent Floridas importation of drugs from that country to cause a shortage in Canada.