Titles
- Competitive generic therapies: guidance for industry1
- Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards1
- Considerations for the development of dried plasma products intended for transfusion1
- Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry1
- Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff1
- Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry1
- Delays in confirmatory trials for drug applications granted FDA’s accelerated approval raise concerns1
- Determining whether to submit an ANDA or a 505(b)(2) application1
- Development of abbreviated new drug applications during the COVID-19 pandemic: questions and answers1
- Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry1
- Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff1
- Drug products, including biological products, that contain nanomaterials1
- E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)1
- Electronic submission of IND safety reports: technical conformance guide1
- Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders1
- Evaluation of devices used with regenerative medicine advanced therapies1
- Evaluation of internal standard responses during chromatographic bioanalysis: questions and answers1
- Failure to respond to an ANDA complete response letter within the regulatory timeframe1
- Failure to respond to an ANDA complete response letter within the regulatory timeframe: guidance for industry1
- Field alert report submission: questions and answers1