Titles
- Complicated intra-abdominal infections: developing drugs for treatment1
- Complicated urinary tract infections: developing drugs for treatment1
- Compounded drug products that are essentially copies of a commercially available drug product under Section 503A of the Federal Food, Drug, and Cosmetic Act1
- Compounded drug products that are essentially copies of approved drug products under Section 503B of the Federal Food, Drug, and Cosmetic Act1
- Considerations for design, development, and analytical validation of next generation sequencing (NGS)--based in vitro diagnostics (IVDs) intended to aid in the diagnosis of suspected germline diseases: guidance for stakeholders and Food and Drug Administration staff1
- Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)1
- 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
- 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
- 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
- Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment1
- E11(R1) addendum: clinical investigation of medicinal products in the pediatric population1
- E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)1
- E17 general principles for planning and design of multiregional clinical trials1
- E18 genomic sampling and management of genomic data1
- E6(R2) good clinical practice: integrated addendum to ICH E6(R1)1