This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:
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SBIA Learn offers a variety of multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small pharmaceutical business and industry.
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GDUFA III includes several enhancements to the ANDA assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements aim to reduce the number of assessment cycles and facilitate timely access to safe, effective, high-quality, and affordable generics.
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On September 18 and 19, 2025, the U.S. Food and Drug Administration (FDA) is hosting a virtual public workshop to discuss methodological challenges related to patient experience data encountered, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other ar
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FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs in a searchable and filterable table format
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Generic Drugs - Specific Labeling Resources
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CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
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CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

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Generic Drug Facilities, Sites and Organization Lists
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Information on patents and suitability petitions that impact the availability of generic drugs.
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Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
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This guidance is the third in a series of four methodological patient-focused drug development guidances that describe how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers to be used for product development decision-making.
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