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Titles
- Assessing the credibility of computational modeling and simulation in medical device submissions: guidance for industry and Food and Drug Administration staff1
- Benefit-risk assessment for new drug and biological products: guidance for industry1
- Compliance policy regarding blood and blood component donation suitability, donor eligibility and source plasma quarantine hold requirements: guidance for industry1
- Development and licensure of vaccines to prevent COVID-19: guidance for industry1
- Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry1
- Digital health technologies for remote data acquisition in clinical investigations: guidance for industry, investigators, and other stakeholders1
- Direct-to-consumer prescription drug advertisements: presentation of the major statement in a clear, conspicuous, and neutral manner in advertisements in television and radio format final rule : questions and answers : guidance for industry1
- Enforcement policy for certain supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for clinical electronic thermometers: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring: guidance for industry and Food and Drug Administration staff1
- Human prescription drug and biological products: labeling for dosing based on weight or body surface area for ready-to-use containers : “dose banding” : guidance for industry1
- Notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act: guidance for industry and Food and Drug Administration staff1
- Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol: guidance for industry1
- Q5A(R2): viral safety evaluation of biotechnology products derived from cell lines of human or animal origin : guidance for industry1
- Rare diseases: considerations for the development of drugs and biological products : guidance for industry1
- Real-time oncology review (RTOR): guidance for industry1
- Real-world data: assessing registries to support regulatory decision-making for drug and biological products : guidance for industry1
- Reformulating drug products that contain carbomers manufactured with benzene: guidance for industry1
- Registration and listing of cosmetic product facilities and products: guidance for industry1
- Submitting clinical trial datasets and documentation for clinical outcome assessments using Item Response Theory: guidance for industry : technical specifications document1