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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

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

FDA Clears Sofwave Wrinkle-treating Ultrasound

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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

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

Canon Optical Coherence Tomography Cleared

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FDA clears a Canon 510(k) for its Xephilio OCT-A1 Optical Coherence Tomography device for in-vivo imaging and measurement of the r...

First Project Orbis Action with Australia, Canada

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FDA, Australia, and Canada collaborate for the first Project Orbis simultaneous drug approval for Lenvima and Keytruda to treat a ...

Five OPDP Research Studies Awaiting Publication

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The Coalition for Healthcare Communication reports that five research studies conducted by CDERs Office of Prescription Drug Promo...

Changes Sought in FDA Pharmacokinetics Guidance

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Five stakeholders recommend changes to an FDA draft guidance on population pharmacokinetics.