FDA releases final guidance on anthelmintic drug effectiveness testing in felines to facilitate international acceptance of study data for veterinary medicinal product registration.
FDA Guidance for Industry #114 provides study design recommendations for anthelmintic drugs in chickens to support universal acceptance of effectiveness data across national and regional veterinary medicinal product requirements.
FDA releases final guidance on effectiveness study design recommendations for anthelmintic drugs in sheep to standardize international regulatory acceptance of veterinary medicinal products.
FDA issues draft guidance on master protocols for drug and biological product development, clarifying design, analysis, and submission requirements for randomized trials demonstrating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FDA draft guidance recommends using quantitative systems pharmacology modeling to determine starting doses for first-in-human trials of drugs and biologics with potent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 releases final guidance for industry on anthelmintic drug effectiveness testing in goats and sheep, establishing study design standards for veterinary medicinal product registration across international markets.
FDA's revised draft guidance clarifies how pharmaceutical manufacturers can demonstrate substantial evidence of drug effectiveness through one adequate well-controlled clinical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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