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Senator Probing Drug Shortages, Prices

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Michigan Sen. Gary Peters say he intends to investigate solutions to increasing drug prices and drug shortages.

ASCA Pilot Should Help Device Premarket Review: CDRH

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CDRHer Stacy Cho outlines elements in a draft guidance to create an Accreditation Scheme for Community Assessment pilot program.

FDA Approves Fluzone High-Dose Quadrivalent

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FDA approves a Sanofi supplemental BLA for Fluzone High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age an...

FDA Alliance Advocates for Increased FDA Funding

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The Alliance for a Stronger FDA advocates for increased FDA funding in fiscal year 2020 because growing responsibilities require a...

Zimmer ROSA Brain System Recall Class 1

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FDA says the Zimmer Biomet recall of ROSA 3.0 robotic surgery systems is Class 1.

Tripartite Meeting Looks at Antibacterial Regulation

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Representatives from FDA, the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency are working on...

Equipment Contamination Seen in 2 Aurobindo Inspections

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Indias The News Minute says FDA inspections at two Aurobindo drug manufacturing facilities raised concerns about equipment contami...

Conformis Hip System Cleared

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FDA clears a Conformis 510(k) for its Conformis Hip System.

FDA Needs AI Standards: Executive

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Charles Fisher, who founded an artificial intelligence company that works in drug clinical trials, urges FDA to develop a framewor...

FDA in 2 Collaborative Communities

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CDRHer Michelle Tarver says FDA is participating in two collaborative communities and wants to be in 10 by the end of 2020.