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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.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Hubei Danjiangkou Danao Pharmaceutical and Vita-Pure.

Abuse-Deterrent Generic Opioid Guidance

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FDA commissioner Scott Gottlieb says the agency has issued a new guidance and taken other steps to help sponsors test and seek app...

Comments Sought on Info Collection Under 513(g) Devices

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Federal Register notice: FDA seeks comments on an information collection extension for 513(g) Request for Information OMB Control ...