💊FDA Notice on Regulatory Review Period for XOLREMDI Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XOLREMDI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Learn More💊FDA Issues Regulatory Review Period for VOWST Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VOWST and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💊FDA Notice for Oncologic Drugs Advisory Committee Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Learn More🍽️FDA Seeks Comments on Manufactured Food Regulatory Program Standards
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information associated with our Manufactured Food Regulatory Program Standards (MFRPS).
Learn More🏥FDA Patent Extension Notification for Navitor Valve
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Learn More🏥FDA Review Period Determination for Impella RP Flex Medical Device
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMPELLA RP FLEX WITH SMART ASSIST and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Learn More💊FDA Notice on Patent Extension for POMBILITI Regulatory Review
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for POMBILITI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More🧀FDA Permits Market Testing of Innovative Cheese Product
The Food and Drug Administration (FDA or we) is announcing an amendment to the temporary permit issued to Bongards' Creameries to market test pasteurized process cheese deviating from the standard of identity for these cheeses by using extra virgin olive oil as the slice anti-sticking agent. We are also announcing an extension to this permit, which allows Bongards' Creameries to continue to evaluate commercial viability of the product and to collect data on consumer acceptance of the product in support of a petition to amend the standard of identity. We invite other interested parties to participate in the market test.
Learn More🌡️FDA Exempts Class II Clinical Electronic Thermometers from Regulations
The Food and Drug Administration (FDA, we, or the Agency) is publishing an order setting forth the Agency's final determination to exempt certain class II clinical electronic thermometers from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for such class II clinical electronic thermometers. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulations. FDA is amending the classification language within the Code of Federal Regulations for certain class II clinical electronic thermometers to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Learn More🚬FDA Notice on Modified Risk Tobacco Products for ZYN by Swedish Match
The Food and Drug Administration (FDA or Agency) is announcing an opportunity to provide public comment on modified risk tobacco product applications (MRTPAs) submitted by Swedish Match U.S.A., Inc. for ZYN oral pouch products containing nicotine derived from tobacco.
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