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Titles
- ANDA submissions--amendments to abbreviated new drug applications under GDUFA1
- Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases1
- Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases1
- Considerations for the development of dried plasma products intended for transfusion1
- Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff1
- Determining whether to submit an ANDA or a 505(b)(2) application1
- Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff1
- E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)1
- 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
- Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff1
- Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance1
- Health document submission requirements for tobacco products: (revised)1
- Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination1
- M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use1
- M4E(R2): the CTD--efficacy1
- Maximal usage trials for topically applied active ingredients being considered for inclusion in an over-the -counter monograph: study elements and considerations1
- Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application1
- Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers1