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 …
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 …
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 …
COVID-19 Update for Diagnostic Device Manufacturers Read More »
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 …
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 …
FDA implements 21st Century Cures Act Requirements for Reusable Devices Read More »
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 …
OFW Law Supports Medical Device Innovators at the 2017 Rice Business Plan Competition Read More »
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