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FDA Clears Erchonia Laser for Musculoskeletal Pain

[ Price : $8.95]

FDA clears an Erchonia 510(k) to market FX low-level laser for the temporary relief of chronic, nociceptive musculoskeletal pain.

ICH Meeting on Updated Trial Considerations

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FDA announces a 10/31 ICH Global Meeting on E8 Guideline on General Considerations for Clinical Trials to discuss a planned revisi...

BD Recalls Alaris Infusion Sets

[ Price : $8.95]

Becton Dickinson recalls its Alaris Infusion Sets due to the potential for faster than expected delivery of medication (over-infus...

Value of Risk-Based Quality Management

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Presenters at an FDA/Duke Margolis Center conference discuss FDA interest in risk-based quality management, including clinical tri...

FDA Accepts Allergans Bimatoprost SR NDA

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FDA is expected to act by mid-2020 on an Allergan NDA for Bimatoprost SR indicated for reducing intraocular pressure in patients w...

FY 2018 OGD Research Grants

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The Office of Generic Drugs science and research report for FY 2018 says 13 research contracts and 11 grants for innovative resear...

Info Collection Extension for CDRH Appeals Process

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Federal Register notice: FDA submits to OMB an information collection extension for Center for Devices and Radiological Health App...

Novartis Reserves $700 Million to Settle Whistleblower Suit

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Novartis says it has reserved about $700 million to settle U.S. government allegations that it illegally enticed physicians to pre...

Horizon NDA Accepted for New Procysbi Dosage Form

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FDA accepts for review a Horizon Therapeutics NDA for a new dosage form for Procysbi (cysteamine bitartrate) delayed-release oral...

Consent Decree Entered Against J and L Grocery

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An Arkansas federal court orders J and L Grocery (Alma, AR) to stop distributing drug products, medical devices, cosmetics and foo...