🧪FDA Announces Public Meeting on Biosimilar User Fee Act III
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Biosimilar User Fee Act (BsUFA) III Regulatory Science Program Interim Public Meeting" and the availability of the report entitled "BsUFA III Regulatory Science Pilot Program Interim Report." The purpose of the public meeting is to review the progress of the BsUFA III Regulatory Science Program aims, or demonstration projects, and to solicit input on future research priorities. Under the BsUFA reauthorization commitment letter for fiscal years (FYs) 2023 through 2027 (BsUFA III), FDA committed to piloting a regulatory science program to facilitate biosimilar and interchangeable product development that focuses on: (1) advancing the development of interchangeable products; and (2) improving the efficiency of biosimilar product development. The purpose of the interim progress report is to provide a summary of activities that established the pilot program, an overview of research progress, and a brief discussion of future directions.
Learn More💊FDA Patent Extension Review for TECELRA and Business Implications
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TECELRA 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💊Exclusive Patent License for CNS Therapeutics by NIH
The National Institute of Neurological Disorders and Stroke and the National Center for Advancing Translational Sciences, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Psycala Bio, Inc. (Psycala), incorporated in Delaware.
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💰NIH Announces Closed Grant Review Meetings for Businesses
The Department of Health and Human Services provides notice of upcoming closed meetings related to the review of grant applications at the National Institutes of Health. These meetings are designated for the evaluation of various health and scientific topics, and specific committees are tasked with assessing applications relevant to small business activities and scientific advancements.
Learn More💉NIH Announces Closed Meeting for Grant Application Reviews
The National Institute of Allergy and Infectious Diseases has announced a closed meeting to review grant applications related to allergy, immunology, and infectious diseases research. The meeting aims to evaluate various clinical trial planning grants and cooperative agreements. Due to the confidential nature of the discussions, this meeting will not be open to the public.
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