- Cybersecurity in medical devices: quality system considerations and content of premarket submissions : guidance for industry and Food and Drug Administration staff1
- Cybersecurity in medical devices: refuse to accept policy for cyber devices and related systems under section 524B of the FD&C Act : guidance for industry and Food and Drug Administration staff1
- DSCSA standards for the interoperable exchange of information for tracing of certain human, finished, prescription drugs: guidance for industry1
- Definitions of suspect product and illegitimate product for verification obligations under the Drug Supply Chain Security Act: 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
- Drug-drug interaction assessment for therapeutic proteins: 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 face masks and barrier face coverings during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for face shields, surgical masks, and respirators during the coronavirus disease (COVID-19) public health emergency: 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
- Enhanced drug distribution security at the package level under the Drug Supply Chain Security Act: guidance for industry1
- Evaluation of gastric pH-dependent drug interactions with acid-reducing agents: study design, data analysis, and clinical implications : guidance for industry1
- Foreign supplier verification programs for importers of food for humans and animals: guidance for industry1
- Format and content of a REMS document: guidance for industry1
- Fostering medical device improvement: FDA activities and engagement with the voluntary improvement program : guidance for industry and Food and Drug Administration staff1
- General considerations for animal studies intended to evaluate medical devices: guidance for industry and Food and Drug Administration staff1