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FDA Unsatisfied with Philips Respironics Recall

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CDRH director Jeffrey Shuren says FDA believes there is more Philips Respironics needs to do as part of its recall of ventilators ...

Stimulant Use Disorder Treatment Guidance

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FDA publishes a draft guidance to assist sponsors in developing drugs and biologics to treat stimulant use disorders.

Orphan Status for Pancreatic Cancer Drug

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FDA grants Noxopharm an Orphan Drug Designation for CRO-67, a drug candidate for treating pancreatic cancer.

Medtronic Warns on Stolen Laryngoscopes

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Medtronic warns healthcare professionals about stolen defective McGRATH MAC video laryngoscopes that have been offered for sale il...

No Safety Issues in Biosimilar Switches: Study

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FDA researchers say they found no difference in safety when patients were switched between interchangeable biosimilars and the ref...

Objectionable Conditions at Florida Doctor Site

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FDA warns Atlantis, FL-based Dr. Luis Pena-Hernandez about objectionable conditions in his work conducting a clinical investigatio...

Biomic Sciences Recalls Contaminated Sprays

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Biomic Sciences recalls all lots of ION Sinus Support, ION Biome Sinus, and Restore Sinus Spray products due to microbial contamin...

Attorney Blasts CDRH for 8,000-day Petition Delays

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Attorney and data scientist Bradley Thompson blasts CDRH for its lengthy delays of up to 8,000 days in answering an average of 13 ...

User Fee Courier Delivery Address Change

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Federal Register notice: FDA provides notice that the courier address used for user fee payments has changed effective 10/6.

BD Vacutainers EUA Revoked

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Federal Register notice: FDA announces that it revoked the Emergency Use Authorization issued to Becton, Dickinson for the BD Vacu...