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Emergency Use Revoked for Luminex Zika Assay

[ Price : $8.95]

Federal Register notice: FDA revokes an emergency use authorization issued to Luminex for the xMAP MultiFLEX Zika RNA Assay.

Software Pre-certification May Mean More Surveillance: Attorney

[ Price : $8.95]

Attorney Vernessa Pollard says that medical device software pre-certification may lead to greater post-market surveillance and dat...

PhRMA Proposes Changes to Opioid Benefit/Risk Framework

[ Price : $8.95]

PhRMA recommends changes to an FDA draft guidance on a benefit/risk framework for evaluating prescription opioids.

Using Highlights in Failure-to-Warn Preemption

[ Price : $8.95]

Attorney James Beck says attorneys should argue for preemption of failure-to-warn claims that covers any informational claims that...

California Bill Says Pay-for-Delay is Anticompetitive

[ Price : $8.95]

Attorney Sara Koblitz says a California bill would presume that pay-for-delay settlements between branded and generic drug compani...

Company Asks Court to Reverse Roxicodone Rejection

[ Price : $8.95]

Pharmaceutical Manufacturing Research Services asks the DC appeals court to reverse FDA rejection of its Roxicodone abuse-deterren...

FDA Clears Sofwave Wrinkle-treating Ultrasound

[ Price : $8.95]

FDA clears a Sofwave Medical 510(k) its Sofwave system, indicated for treating facial lines and wrinkles.

FDA Breakthrough Status for Sirolimus-Eluting Balloon

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FDA gives Orchestra BioMed a breakthrough device designation for its Virtue Sirolimus-Eluting Balloon for treating below-the-knee ...

CGMP, Registration Violations at Former Deb USA

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FDA warns SC Johnson (formerly Deb USA) about CGMP and other violations in its production of finished pharmaceuticals.

Merck Ebola Vaccine BLA Under Priority Review

[ Price : $8.95]

FDA accepts for priority review a Merck BLA for its investigational Ebola vaccine.