FDA releases final guidance on effectiveness study design recommendations for anthelmintic drugs in sheep to standardize international regulatory acceptance of veterinary medicinal products.
FDA releases final guidance on anthelmintic drug effectiveness testing in felines to facilitate international acceptance of study data for veterinary medicinal product registration.
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FDA's revised draft guidance clarifies how pharmaceutical manufacturers can demonstrate substantial evidence of drug effectiveness through one adequate well-controlled clinical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.
FDA draft guidance recommends using quantitative systems pharmacology modeling to determine starting doses for first-in-human trials of drugs and biologics with potent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FDA issues draft guidance on master protocols for drug and biological product development, clarifying design, analysis, and submission requirements for randomized trials demonstrating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 releases final guidance #95 on anthelmintic effectiveness testing for bovines to harmonize international veterinary drug registration requirements and facilitate data acceptance across regulatory jurisdictions.
FDA releases VICH guidance #90 on anthelmintic effectiveness standards for veterinary medicinal products to enable universal acceptance of study data across national and regional registration requirements.
FDA solicits stakeholder input on an Expedited Investigational New Drug pilot program to accelerate drug development timelines by establishing a network of qualified research institutions to support first-in-human clinical trials.
FDA seeks public comment on a proposed Potential Tobacco Product Violations Reporting Form; 60-day comment period required under the Paperwork Reduction Act of 1995.
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