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Tobacco Product Premarket Deadline Extension OK

[ Price : $8.95]

FDA says the Maryland federal court has approved its requested extension to 9/9 the deadline for manufacturers of some tobacco pro...

Cagent Vascular Serranator Balloon Catheter Cleared

[ Price : $8.95]

FDA clears a Cagent Vascular 510(k) for its Serranator PTA Serration Balloon Catheter for treating below-the-knee lesions.

Temporary Propofol Repackaging, Combining Guidance

[ Price : $8.95]

FDA publishes a temporary policy on repackaging or combining propofol general anesthesia products to help ease a shortage during t...

Steps to Data Integrity Compliance

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ProPharma Group lists steps drug companies can take to best handle planned and unplanned internal and external inspections.

Support for Reclassifying HIV Tests

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Four stakeholders say they support an FDA reclassification of some HIV tests to Class 2 with special controls.

Baxter Gets EUA for Blood Filter

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FDA grants Baxter International an emergency use authorization for the Oxiris filter set to treat patients who have confirmed Covi...

CNS Pharma Seeks Orphan Status for Berubicin

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CNS Pharmaceuticals seeks an FDA orphan drug designation for berubicin for treating glioblastoma.

FDA Ups Seizures of Foreign Drugs

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Kaiser Health News says FDA has increased seizures of drugs being imported into the U.S. from Canada and other countries by indivi...

Trividia Health Recalls 1 True Matrix Meter

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FDA says Trividia Health is recalling a single True Metrix Air blood glucose meter that has an incorrect factory-set unit of measu...

Comments Extended on Gene Therapy Guide

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Federal Register notice: FDA extends the comment period on a 1/30-published draft guidance entitled Interpreting Sameness of Gene ...