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Senators Question FDA Oversight on Covid-19 Products

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Senators Elizabeth Warren (D-MA) and Patty Murray (D-WA) ask FDA how it is tracking the use, safety, and effectiveness of scores o...

Guide on Drugs for Cytomegalovirus in Transplants

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Federal Register notice: FDA makes available a final guidance on developing drugs for cytomegalovirus in transplantation.

Over 1,000 Clinical Trials Halted Due to Covid-19

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A German researcher says that over 1,000 clinical trials having been stopped due to restrictions brought on by the Covid-19 virus.

FDA Posts Performance Data on Antibody Tests

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FDA posts summarized performance data for 12 antibody (serology) tests that have been granted emergency use authorizations for det...

Apotex Pays $24 Million in Price Fixing Scheme

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Apotex agrees to pay a $24.1 million criminal penalty and admit that it conspired with other generic drug sellers to artificially ...

Bexion Wins Orphan Status for Pediatric Glioma Drug

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FDA grants Bexion Pharmaceuticals an orphan drug designation for BXQ-350 and its use for treating malignant glioma, including diff...

42 Warning Letters on Covid Scam Products

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FDA says it has sent 42 Warning Letters to companies making bogus claims for Covid-19 products online.

FDA OKs Moderna Covid Vaccine for Phase 2

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FDA authorizes a Phase 2 study of Modernas mRNA-1273 SARS-CoV-2 vaccine candidate.

FDA Safety Concerns on China Facepiece Respirators

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FDA alerts healthcare providers about certain filtering facepiece respirators from China may not provide consistent and adequate r...

Messages Cut Inappropriate Antibiotic Scrips: Study

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A Medscape/FDA study finds that online messaging and CME can reduce the incidence of inappropriate antibiotic prescribing.