Titles
- Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)1
- Control of nitrosamine impurities in human drugs1
- Conventional Foley catheters--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff1
- Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff1
- Cutaneous electrodes for recording purposes--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff1
- Cytomegalovirus in transplantation: developing drugs to treat or prevent disease1
- 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
- Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment1
- E11(R1) addendum: clinical investigation of medicinal products in the pediatric population1