Titles
- Compounded drug products that are essentially copies of approved drug products under Section 503B of the Federal Food, Drug, and Cosmetic Act1
- Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff1
- 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
- Considerations for the development of dried plasma products intended for transfusion1
- Considerations for the inclusion of adolescent patients in adult oncology clinical trials1
- Considerations in demonstrating interchangeability with a reference product1
- Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)1
- Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff1
- 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
- Delayed graft function in kidney transplantation: developing drugs for prevention1
- Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff1
- Determining whether to submit an ANDA or a 505(b)(2) application1
- 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
- Drug supply chain security: wholesalers exchange most tracing information1
- Drugs for treatment of partial onset seizures: full extrapolation of efficacy from adults to pediatric patients 2 years of age and older1