Notice 20 May 2025 regulatory compliance, healthcare, fda, chemotherapy, fluorouracil, dihydropyrimidine dehydrogenase

💉FDA Notice on DPD Deficiency and Fluoropyrimidine Drugs

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit public comment for information on dihydropyrimidine dehydrogenase (DPD) deficiency and the use of fluorouracil and capecitabine (both fluoropyrimidine chemotherapy drugs). The purposes of the docket establishment are to foster Agency transparency and to solicit input on the currently available information on DPD deficiency and the use of fluorouracil and capecitabine.

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Notice 19 May 2025 regulatory compliance, public meeting, fda, pharmaceutical, user fees, prescription drug user fee act

💊FDA Meeting on Reauthorization of Prescription Drug User Fee Act

The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032. PDUFA authorizes FDA to collect user fees to support the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin the PDUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2028 through 2032. These comments will be published and available on FDA's website.

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Notice 19 May 2025 regulatory compliance, public meeting, healthcare, fda, user fees, generic drugs, drug manufacturing

💊FDA Announces Public Meeting on Generic Drug User Fee Reauthorization

The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 to 2032. At the end of September 2027, new legislation will be required for FDA to continue to collect generic drug user fees for future FYs. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization; hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (i.e., the GDUFA III Commitment Letter) (https://www.fda.gov/industry/ generic-drug-user-fee-amendments/gdufa-iii-reauthorization); provide a period of 30 days after the public meeting to obtain written comments from the public; and publish the comments on FDA's website. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program cycle. These comments will be published and available on FDA's website.

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Notice 19 May 2025 healthcare, regulations, fda, drug approval, biologics, patent extension, elahere

💊FDA Notice on Regulatory Review Period for ELAHERE Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELAHERE 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.

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Rule 19 May 2025 regulatory compliance, fda, food additives, animal feeds, animal feed, selenium

🐔FDA Updates Regulations on Food Additives for Animal Feed

The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of zinc L- selenomethionine as a source of selenium in complete feed for broiler chickens. This action is in response to a food additive petition filed by Zinpro Corp.

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Notice 14 May 2025 healthcare, pharmaceuticals, fda, drug regulation, biotechnology, patent extension

💊FDA Determines Regulatory Review Period for ADBRY Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADBRY 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.

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Notice 14 May 2025 regulatory compliance, pharmaceuticals, fda, biotechnology, patent extension, human biological products

💊FDA Determination on EPKINLY Patent Extension and Regulatory Review

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EPKINLY 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 patents which claims that human biological product.

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Notice 14 May 2025 regulatory compliance, nutrition, fda, health, consumer safety, food industry, infant formula

🍼FDA Requests Information on Infant Formula Nutrient Requirements

The Food and Drug Administration (FDA or we) is requesting information and data to begin the nutrient review process for infant formula. We are taking this action, in part, to continue to ensure the nutritional adequacy of infant formula sold in the United States. We intend to use the information and data to help determine what type(s) of actions, if any, should be taken.

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Notice 14 May 2025 regulations, business compliance, fda, medical devices, patent extension

💉FDA Notice on SKINVIVE Patent Extension Regulatory Review

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SKINVIVE 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 medical device.

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Notice 14 May 2025 pharmaceuticals, fda, regulatory review, biologics, patent extension, omvoh

💊FDA's Patent Extension Determination for OMVOH

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OMVOH 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.

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