💊Licensing Opportunities for RXFP1 Agonists by NIH
The National Center for Advancing Translational Sciences (NCATS), an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the licensing opportunities for the inventions listed below, which are owned by an agency of the U.S. Government, Florida International University (FIU), and University of South Florida (USF). The NCATS has taken the lead in both patenting and licensing via consolidation of rights under an Inter Institutional Agreement (IIA). The inventions are available for licensing and collaboration to achieve expeditious commercialization results of federally funded research and development.
Learn More💊FDA Determines Heparin Sodium Products Not Withdrawn for Safety
The Food and Drug Administration (FDA or Agency) has determined that HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 milliliters (mL); HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL; HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 10,000 units/100 mL; and HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL under new drug application (NDA) 019802 were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these products if all other legal and regulatory requirements are met.
Learn More💊FDA Notice on Patent Extension for IQIRVO Drug Review Period
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IQIRVO 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's Regulatory Review Notice for NEMLUVIO Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NEMLUVIO 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 Regulatory Review Period and Patent Extension for PIASKY
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PIASKY 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 Announces Regulatory Review Period for YORVIPATH Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for YORVIPATH 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 claim that human drug product.
Learn More💊DEA Notice on Continuus Pharmaceuticals' Bulk Manufacturing Application
Continuus Pharmaceuticals has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊Public Meeting on Financial Transparency for Prescription Drug Fees
The Food and Drug Administration (FDA or the Agency) is announcing the following public meeting entitled "Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments." The topic to be discussed is the financial transparency and efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.
Learn More💊Cambrex High Point Applies for Controlled Substances Manufacturing
Cambrex High Point, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊FDA Confirms RIFADIN Capsules Not Withdrawn for Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that RIFADIN (rifampin) capsules, 150 milligrams (mg) and 300 mg, were not withdrawn from sale for reasons of safety or effectiveness to the extent that the drugs can be manufactured or formulated in a manner that satisfies any applicable acceptable intake limit for nitrosamine impurities. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements, including satisfying any applicable acceptable intake limit for nitrosamine impurities.
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