🌽Nonregulated Status of Bayer's Genetically Engineered Maize Announced
We are advising the public of our determination that MON 95379 Lepidopteran-Protected Maize (corn), which was developed using genetic engineering to produce two insecticidal proteins to protect against feeding damage caused by target lepidopteran pests, is no longer considered regulated. Our determination is based on our evaluation of information and data Bayer U.S.-Crop Science submitted in its petition for a determination of nonregulated status, available scientific data, the plant pest risk assessment, and public comments received in response to a previous notice announcing the availability of the petition for nonregulated status and a draft plant pest risk assessment. This notice announces the availability of our written determination and the availability of the final plant pest risk assessment.
Learn More💊Exclusive License for Zika Virus Therapy by NIH and Advocate Aurora
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Advocate Aurora Research Institute, located in Milwaukee, Wisconsin, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
Learn More🧬FDA Guidance on Postapproval Safety and Efficacy for CGT Products
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry." The draft guidance document discusses methods and approaches for capturing postapproval safety and efficacy data for cell and gene therapy (CGT) products. Given the potential for long-lasting effects of CGT products, and the generally limited number of participants treated in clinical trials, the collection of postapproval study data for CGT products is important for gathering data on product safety and effectiveness over time.
Learn More💵NIH Grants Review Meetings and Opportunities for Businesses
The Department of Health and Human Services announces closed meetings of the Center for Scientific Review. These meetings focus on evaluating grant applications, which include essential financial support for businesses engaged in scientific research, drug discovery, and related fields. Each meeting provides contact information for interested parties.
Learn More💊Notice of Investigation on Drug Patent Complaint Amendment
Notice is hereby given that the U.S. International Trade Commission ("Commission") has determined not to review an initial determination ("ID") (Order No. 15) of the presiding Chief administrative law judge ("Chief ALJ") granting Complainant's motion to amend the complaint and notice of investigation.
Learn More🧬Prospective Exclusive Patent License for Cancer Treatment Innovations
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an NCI Exclusive Patent License to practice the inventions embodied in the patents listed in the Supplementary Information section of this notice to Lysin Therapeutics, Inc. (Lysin), a company located in Silver Spring, MD.
Learn More🌸USDA's Nonregulated Status Determination for Genetically Engineered Orchid
We are advising the public of our determination that ISK- 311NR-4 phalaenopsis (moth orchid), which was developed using genetic engineering to produce a blue-purple flower color, is no longer considered regulated. Our determination is based on our evaluation of information and data Ishihara Sangyo Kaisha, Limited submitted in its petition for a determination of nonregulated status, available scientific data, the plant pest risk assessment, and public comments received in response to a previous notice announcing the availability of the petition for nonregulated status and a draft plant pest risk assessment. This notice announces the availability of our written determination and supporting documents.
Learn More🌿FDA Notification of Food Additive Petition for Animal Use
The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Biomin GmbH, proposing that we amend our food additive regulations to provide for the safe use of zearalenone hydrolase to degrade zearalenone in swine food at no less than 10 U/kg complete feed (U = the five-fold enzymatic activity that hydrolyzes 1 [micro]mol zearalenone per minute in a solution of 5 mg/L zearalenone).
Learn More💊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 Notice on CAMZYOS Patent Extension and Review Period
The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Register of February 29, 2024. After review of the calculation of the applicable regulatory review period of the biologic product CAMZYOS (U.S. patent numbers 9,181,200; 9,585,883) in that notice, FDA has determined that a revision of the supplementary information section is warranted. This notice corrects the applicable regulatory review period language.
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