On July 21, 2016, the FDA will hold a webinar for industry to review the Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” final guidance document. The recommendations in this final guidance clarify and update how medical device developers may use…
Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication
Including the following currently available fluoroquinolones Avelox (moxifloxacin) Cipro (ciprofloxacin) Cipro extended-release (ciprofloxacin extended-release)Factive (gemifloxacin) Levaquin (levofloxacin) Ofloxacin (generic brand) [Posted 07/26/2016] AUDIENCE: Family Practice, Infectious Disease, Neurology, Pharmacy, Patient ISSUE: FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated…
Adaptive Designs for Medical Device Clinical Studies
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150030 added)
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Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
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Presentations posted for July 21-22, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee
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Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)
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24 Hour Summary (Dexcom) posted for July 21, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee
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Patient and Provider Notification (PPN): What to expect if your facility is ordered to perform a PPN
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HCG and Sermorelin by Talon Compounding Pharmacy: Recall
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