FDA received a food additive petition from Sterigenics U.S., LLC proposing ionizing radiation for pathogen reduction in raw enriched wheat flour.
Center for Scientific Review will hold closed meetings to review grant applications for National Institutes of Health funding across multiple scientific disciplines.
Center for Scientific Review announces an amended meeting notice with updated date, time, or location details for its scientific review panel proceedings.
HRSA publishes notice of petitions received under the National Vaccine Injury Compensation Program, with the U.S. Court of Federal Claims responsible for adjudication as required by the PHS Act.
FDA issues draft guidance on master protocols for drug and biological product development, clarifying design, analysis, and submission requirements for randomized trials demonstrating safety and efficacy across therapeutic areas.
FDA draft guidance recommends using quantitative systems pharmacology modeling to determine starting doses for first-in-human trials of drugs and biologics with potent pharmacological effects like cytokine release.
FDA's revised draft guidance clarifies how pharmaceutical manufacturers can demonstrate substantial evidence of drug effectiveness through one adequate well-controlled clinical investigation plus confirmatory evidence, replacing 1998 standards.
SAMHSA is providing supplemental funding up to $1,198,000 through September 29, 2029 to one eligible FY 2024 Prevention Technology Transfer Centers grant recipient for developing a substance use prevention fellowship program.
The Department of Health and Human Services requests public input on whether safe harbor regulations under the Federal Anti-Kickback Statute and Beneficiary Inducements CMP need modifications for remuneration related to clinical trial participation.
National Institutes of Health Director's office will hold a closed meeting to discuss grant applications, personnel matters, and contract negotiations affecting biomedical research funding.
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