|  FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | FDA In Brief: FDA Provides Guidance on Master Protocols for Evaluating Prevention, Treatment Options for COVID-19 | | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | Today, the U.S. Food and Drug Administration issued a final guidance entitled, "COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Guidance for Industry." This guidance describes FDA's current recommendations to sponsors of master protocols evaluating drugs for the treatment or prevention of COVID-19. A master protocol is defined as a protocol designed with multiple substudies, which involve coordinated efforts to evaluate one or more investigational drugs, in one or more disease subtypes, with one or more objectives, all within the same overall trial structure. This guidance focuses on the design, conduct, and statistical considerations of master protocols intended to generate or contribute to substantial evidence of effectiveness and adequate characterization of safety of drugs for the treatment or prevention of COVID-19. Additionally, this guidance provides administrative and procedural recommendations to sponsors of master protocols for COVID-19 drugs. Find additional information at: This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707. SUBSCRIBER SERVICES: Manage Subscriptions | Unsubscribe All | Help | | | |
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