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Ex-Pharmakon Compliance Director Pleads Guilty to Drug Adulteration

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A former compliance director at Indiana compounding pharmacy Pharmakon Pharmaceuticals pleads guilty to introducing adulterated dr...

Guide on Generic Abuse-deterrent Opioids

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Federal Register notice: FDA makes available a guidance entitled General Principles for Evaluating the Abuse Deterrence of Generic...

Panel to Review Clarus Therapeutics Testosterone Replacement

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Federal Register notice: FDA announces a 1/9/2018 Bone, Reproductive and Urologic Drugs Advisory Committee meeting in Hyattsville,...

10th Annual Sentinel Public Workshop

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Federal Register notice: FDA announces a 2/7-8/2018 public workshop entitled Tenth Annual Sentinel Initiative Public Workshop.

Pro and Con Opinions on Broadcast Ad Major Statement

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Several stakeholders support an FDA plan to reduce the amount of risk information in DTC broadcast ads, while one opposes it.

Database Studies Can Support sNDAs: Study

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A Harvard Medical School study finds it may be possible to use nonrandomized real-world data to provide supportive evidence in est...

Zolpimist Web Page, Exhibit Panels Misbranded: FDA

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The CDER Office of Prescription Drug Promotion warns Amherst and Magna about false and misleading statements on a Web page and exh...

Medicrea 3D-printed Titanium Interbodt Devices Cleared

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FDA clears a Medicrea Group 510(k) for its IB3D range of 3D-printed Titanium interbody devices with its AdapTEK in-house additive ...

Janssen Files sBLA for Datzalex in Multiple Myeloma

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Janssen Biotech files a supplemental BLA for Darzalex (daratumumab) and its expanded use in combination with bortezomib, melphalan...

FDA Approves Adjustable Implanted Cataract Lens

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FDA approves a RxSight adjustable intraocular lens for use following cataract surgery.