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resourcesAs a service to our clients, we provide the following definitions and links to resources for product development, clinical trial information, and regulatory guidance. DEFINITIONS FAST-TRACK: The FDA established its Fast Track Drug Development Programs in response to the Food and Drug Administration Modernization Act of 1997, which authorized the FDA to take actions to facilitate the development and expedite the review of new drugs designated by the FDA as demonstrating the potential to address serious unmet medical needs. For a new drug to be designated a Fast Track Product, the condition it is designed to treat must be serious or life-threatening, and must represent an unmet medical need. The FDA also must determine that the drug has the potential to address the unmet medical need and that the development program is designed to evaluate this potential. ANIMAL RULE: Under the Bioterrorism Act of 2002, the FDA specified the evidence required to demonstrate the efficacy of new drug and biological products used to counter biological agents, when traditional efficacy studies in humans are not feasible. According to the guidelines set forth in the Bioterrorism Act, successful studies in relevant animal models will be considered sufficient to establish efficacy for licensure and marketing approval. According to the guidelines, clinical trials will be required to establish safety, tolerability, and pharmacology, but not efficacy. HELPFUL LINKS |
