🧬FDA's CMC Development and Readiness Pilot Program Overview
The Food and Drug Administration (FDA or Agency) is announcing year four of the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP). This program facilitates the expedited CMC development of products under an investigational new drug application (IND) based on the anticipated clinical benefit of earlier patient access to the products. FDA has implemented this pilot program to assist with CMC readiness for products regulated by both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) that have accelerated clinical development timelines. To accelerate CMC development and facilitate CMC readiness, the pilot features increased communication between FDA and sponsors and explores the use of science- and risk-based regulatory approaches, as applicable. This notice outlines the eligibility criteria and process for submitting a request to participate in the pilot.
Learn More📈Analysis of Proposed Cboe BZX Rule Change for TRX ETF
The Securities and Exchange Commission is considering a proposed rule change by Cboe BZX Exchange to list and trade shares of the Canary Staked TRX ETF. The proposal aims to allow the Trust to hold TRX and trade shares while seeking to track TRX's performance, raising discussions about regulatory compliance and investor protection.
Learn More🌍EPA Seeks Public Comment on Pesticide Exemption for ISS
EPA is announcing a specific exemption request from the National Aeronautics and Space Administration (NASA) to use the pesticide ortho-phthalaldehyde (OPA, CAS No. 643-79-8) to treat the coolant fluid of the internal active thermal control system (IATCS) of the International Space Station (ISS) to control aerobic/ microaerophilic bacteria in the aqueous coolant. The applicant proposes the use of a new chemical which has not been registered by EPA. Therefore, in accordance with the Code of Federal Regulations, EPA is soliciting public comment before making the decision whether to grant the exemption.
Learn More🍀FDA Issues Priority Review Voucher for Rare Pediatric Drug
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that MODESYO (dordaviprone), approved August 6, 2025, manufactured by Chimerix, Inc., meets the criteria for a priority review voucher.
Learn More🌐Global Business Identifier (GBI) Information Collection Notice
The Department of Homeland Security, U.S. Customs and Border Protection (CBP) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies.
Learn More⚛️Proposed Extension of Nuclear Fuel Data Survey Regulations
DOE invites public comments on the proposed three-year extension, with changes, to the Form GC-859 Nuclear Fuel Data Survey, OMB Control Number 1901-0287, as required under the Paperwork Reduction Act of 1995. Form GC-859 Nuclear Fuel Data Survey collects data on spent nuclear fuel from all utilities that operate commercial nuclear reactors and from all others that possess irradiated fuel from commercial nuclear reactors.
Learn More🏦Notice on Bank Holding Companies
The Federal Reserve System has issued a notice regarding the formation, acquisition, and merger of bank holding companies. Companies have applied to acquire banks and other entities, with public comments invited on these applications. Consumers can access application details at respective Federal Reserve banks, promoting transparency in financial operations.
Learn More❌CPSC Terminates Proposed Disclosure Rule for Commission Proceedings
The Consumer Product Safety Commission is withdrawing its proposed rule to amend its regulations to require disclosure of relevant interests by persons seeking to make oral presentations, participate in adjudicative proceedings, or submit petitions for rulemaking to the Commission because the Commission has not taken any action on this proposed rule since it was published in September 2023.
Learn More🚗Investigation on Child Car Seats by U.S. ITC Commences
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on July 24, 2025, under section 337 of the Tariff Act of 1930, as amended, on behalf of Wonderland Switzerland AG of Switzerland; Iron Mountains, LLC of Morgantown, Pennsylvania; Nuna International B.V. of the Netherlands; Nuna Baby Essentials, Inc. of Morgantown, Pennsylvania; Joie International Co., Ltd. of Hong Kong; Joie Children's Products, Inc. of Morgantown, Pennsylvania; and Graco Children's Products Inc. of Atlanta, Georgia. Supplements to the complaint were filed on July 30, 2025 and August 13, 2025. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain child car seats by reason of the infringement of certain claims of U.S. Patent No. 7,625,043 ("the '043 patent") and U.S. Patent No. 10,457,168 ("the '168 patent"). The complaint, as supplemented, further alleges that an industry in the United States exists or is in the process of being established as required by the applicable Federal Statute. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
Learn More📊BIS Information Collection Notice
The Department of Commerce's Bureau of Industry and Security seeks public comments on its information collection request related to program evaluations. This initiative aims to gather feedback from businesses about export control seminars, allowing for enhancements to support the exporting community. Comments are welcomed via federal guidelines to improve program relevance and quality.
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