💊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.
Learn More🍼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.
Learn More💉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.
Learn More💊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.
Learn More💊FDA Regulatory Review Period Determination for LAMZEDE Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LAMZEDE 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 Notice on SUNLENCA Regulatory Review Period and Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SUNLENCA 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 drug product.
Learn More🍉Galdieria Extract Blue Approved as Food Color Additive by FDA
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of galdieria extract blue, derived from unicellular red algae (Galdieria sulphuraria), in various food categories at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Fermentalg (Fermentalg or petitioner).
Learn More💊FDA Determines Regulatory Review Period for ELREXFIO Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELREXFIO 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 on NGENLA Regulatory Review Period and Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NGENLA 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 Approves Calcium Phosphate as Safe Color Additive
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. This action is in response to a color additive petition (CAP) filed by Innophos, Inc. (Innophos or petitioner).
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