🏥NIH Grant Evaluation Meetings
The Department of Health and Human Services announces closed meetings for the Center for Scientific Review to evaluate grant applications. Key details include the date, time, agenda, and contact information for relevant NIH officials overseeing these meetings. The outcomes may significantly impact entities seeking research funding in the health sector.
Learn More✈️Summary of FAA's New Falsification Regulations for Aviation
FAA is amending, restructuring, and consolidating the falsification regulations presently located throughout title 14 of the Code of Federal Regulations (CFR). Regarding 14 CFR chapter I, this rule eliminates inconsistencies among the various falsification regulations and associated sanctions; consolidates all existing falsification regulations into one part under 14 CFR chapter I to standardize the existing falsification regulations; and ensures that falsification-related conduct not addressed by pertinent current regulations is covered. This rule also creates a falsification prohibition applicable to the regulations governing commercial space transportation.
Learn More🏥Amended Notice
The Department of Health and Human Services announces a change in the meeting date for the Center for Scientific Review Special Emphasis Panel focused on partnerships for the translation of technologies. The meeting is closed to the public and will now be held on October 16, 2025, rather than October 9, 2025.
Learn More🚫Amylyx Pharmaceuticals' RELYVRIO Drug Approval Withdrawn by FDA
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for RELYVRIO (sodium phenylbutyrate and taurursodiol) for suspension, 3 gram (g)/ packet and 1 g/packet, held by Amylyx Pharmaceuticals, Inc. (Amylyx), 43 Thorndike St., Cambridge, MA 02141. Amylyx has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
Learn More❌FDA Terminates Arthritis Advisory Committee – Regulatory Update
The Food and Drug Administration (FDA or the Agency) is announcing the termination of the Arthritis Advisory Committee (Committee). Due to that termination, this final rule removes the Committee from the Agency's list of standing advisory committees in 21 CFR 14.100.
Learn More📊Proposed Extension of Community Economic Development Performance Report
The Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services is requesting a 3-year extension of the Community Economic Development (CED) Performance Progress Report (PPR) (Office of Management and Budget (OMB) #: 0970-0386, expiration date February 28, 2026) with revisions to support a quarterly reporting schedule. This request revises the burden estimates to reflect new reporting requirements for quarterly reporting. While the core CED PPR form remains unchanged and will still be submitted semi-annually, new awardees must now report quarterly. In alternate quarters (Q1 and Q3), they will complete a shorter version of the form with narrative updates only.
Learn More🧬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💰NIH Notice of Closed Meetings for Grant Application Review
The National Institutes of Health (NIH) announces closed meetings for the review of grant applications concerning various scientific fields. The meetings, aimed at evaluating potential funding opportunities, will take place virtually, ensuring compliance with privacy regulations while discussing critical health research initiatives. Contact information for scientific review officers is also provided.
Learn More📜Delegation of Authority on Substance Use Records Regulation
The Department of Health and Human Services has delegated authority to the Office for Civil Rights to enforce regulations regarding the confidentiality of substance use disorder patient records. This includes the ability to impose penalties for noncompliance, enter resolution agreements, and issue subpoenas related to compliance reviews. This delegation supersedes prior delegations and can be redelegated.
Learn More🧬Meeting Update for National Advisory Council on Human Genome Research
The National Institutes of Health has announced a change in the timing of the National Advisory Council for Human Genome Research meeting. The meeting is set for September 16, 2025, now starting at 09
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