This page features news and information for industry and stakeholders about GDUFA, its fee structure, payment methods, and related information.
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The DSB is composed of representatives from two FDA Centers and eight other federal government agencies, the Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, Department of Defense.
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Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.
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Information and resources for requestors about FDA’s Biomarker Qualification Program
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The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
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FDA’s tips for section 804 state importation program (SIP) proposals provide information to assist states and tribes develop their proposals.
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FDA has issued policies and taken actions to implement section 804 of the Federal Food, Drug and Cosmetic Act, which allows states and Indian tribes to import certain prescription drugs from Canada. Learn more.
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This quality assurance (QA) tool is designed to assist section 804 importation program (SIP) sponsors prepare proposals that fully comply with the requirements under the final rule.
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Section 804 of the Federal Food, Drug and Cosmetic Act allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs without imposing additional risk to public health and safety.
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FDA has developed a pathway under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that allows states and Indian tribes to import certain prescription drugs from Canada. Learn more.
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FDA authorized Florida’s Agency for Health Care Administration’s Section 804 Importation Program (SIP) in accordance with section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s implementing regulations.
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FDA is committed to continuing to work with states and Indian tribes that seek to develop an importation proposal under section 804 of the Federal Food, Drug and Cosmetic Act.
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