Healthcare

FDA announces enforcement discretion and 3-year delay in DSCSA Requirements for Wholesale Distributors and Dispensers

This week, the Food and Drug Administration (FDA) announced release of a new guidance for immediate implementation that extends for another 3 years, until November 27, 2023, its enforcement discretion regarding verification of a prescription drug returns prior to resale.  FDA also announced that it is delaying until November 27, 2023, its requirement that pharmacies …

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QHC for Cranberry Products and Reduced Risk of Recurrent Urinary Tract Infection in Healthy Women

FDA has published a letter of enforcement discretion, which it sent to legal counsel for Ocean Spray Cranberries, Inc., that authorizes a qualified health claim (QHC) for specific cranberry products when consumed in specific amounts by specific people. The substantiation for the diet-disease relationship warranted a “limited and inconsistent” or “limited” scientific evidence qualifier. Based on …

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Testing materials for COVID 19 Corona Virus

COVID-19 Update for Diagnostic Device Manufacturers

The availability of Coronavirus Disease-2019 (COVID-19) diagnostic tests is critical to an effective response to the current pandemic. FDA has taken measures to permit the distribution of such tests in advance of receiving authorization to do so from the agency in an attempt to remove bureaucratic barriers that could affect the nation’s ability to mount …

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Food and Drug Administration logo

FDA Nutrition Innovation Strategy

FDA has announced a public meeting, entitled “FDA’s Comprehensive, Multi-Year Nutrition Innovation Strategy,” (Strategy) to be held on July 26, 2018, from 8:30 a.m. until 5:30 p.m. EDT, at the Hilton Washington DC/Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852. The public meeting also will be made available via live webcast. In March 29, 2018 …

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Stethoscope and a heart

FDA implements 21st Century Cures Act Requirements for Reusable Devices

Last week, the Food and Drug Administration (“FDA”) published a notice in the Federal Register implementing additional requirements for medical devices under the 21st Century Cures Act (“Cures Act”).   Section 3059 of the Cures Act requires FDA to publish a list of reusable device types that must include validated instructions for use, in addition …

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Drone delivering first aid kit

OFW Law Supports Medical Device Innovators at the 2017 Rice Business Plan Competition

On April 8, 2017, Forest Devices, Inc. from Carnegie Mellon University was awarded OFW Law’s Regulatory Strategy Prize at the 2017 Rice Business Plan Competition in Houston, Texas.  Forest Devices bested 41 other competitors hailing from some of the world’s top universities in the overall competition, as well, earning about $700,000 in prize money. Forest …

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