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Medical Devices

FDA Approves Senseonics Eversense Glucose Monitor

FDA approves the Senseonics Eversense continue glucose monitor that uses an implanted sensor to continuously measure glucose levels.

Human Drugs

Purdue Promoted Pseudoaddiction to Defend Oxycontin: CBS

CBS Evening News reports a former Purdue Pharma sales persons claim that the company falsely used pseudoaddiction to minimize the harm blockbuster Oxy...

Human Drugs

FDA Lifts Staar Surgical Warning Letter

FDA issues Staar Surgical a close-out letter that lifts a Warning Letter dated 5/21/2014, a signal that the company has corrected all issues to the ag...

Human Drugs

PDUFA Waiver, Reduction, Refund Guidance

FDA announces availability of a revised draft guidance on drug user fee waivers, reductions, and refunds.

Human Drugs

Court Orders Eagle Bendeka Orphan Exclusivity

The DC federal court orders FDA to grant Eagle Pharmaceuticals orphan drug exclusivity for its cancer drug Bendeka.

Medical Devices

2 Theranos Execs Indicted on Wire Fraud Charges

A federal grand jury indicts the Theranos founder and former chief operating officer on wire fraud charges following an FDA investigation.

Federal Register

Info Collection Extension for Adverse Event Reporting

Federal Register notice: FDA seeks comments on an information collection extension for its Guidance for Industry: Adverse Event Reporting for Outsourc...

Human Drugs

FDA Infectious Disease Designation for Acurx Antibiotic

FDA designates Acurx Pharmaceuticals lead antibiotic product candidate, ACX-362E, as a qualified infectious disease product.

Federal Register

FDA Withdraws Approval of 5 NDAs

Federal Register notice: FDA has withdrawn the approval of five NDAs from multiple applicants.

Medical Devices

FDA Clears TransMed7 SpeedBird Biopsy Platform

FDA clears a TransMed7 510(k) for the SpeedBird platform of soft tissue biopsy devices.