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Titles
- DSCSA standards for the interoperable exchange of information for tracing of certain human, finished, prescription drugs: guidance for industry1
- De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff1
- Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff1
- Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff1
- Definitions of suspect product and illegitimate product for verification obligations under the Drug Supply Chain Security Act: guidance for industry1
- Dental interventions to prevent caries in children: a national clinical guideline1
- Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff1
- Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff1
- 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
- Diagnosis and management of colorectal cancer: a national clinical guideline1
- Diagnosis and management of epilepsy in adults: a national clinical guideline1
- Diagnosis and management of psoriasis and psoriatic arthritis in adults: a national clinical guideline1
- 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
- Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff1
- Dissolution testing and acceptance criteria for immediate-release solid oral dosage form drug products containing high solubility drug substances1
- Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff1
- Drug-drug interaction assessment for therapeutic proteins: guidance for industry1
- Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment1