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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
- Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations1
- Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases1
- Comparability Protocols for postapproval changes to the chemistry, manufacturing, and controls information in an NDA, ANDA, or BLA: guidance for industry1
- Competitive generic therapies: guidance for industry1
- 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
- Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry1
- 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
- Failure to respond to an ANDA complete response letter within the regulatory timeframe: guidance for industry1
- 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
- Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry1
- 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
- M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use1
- M4E(R2): the CTD--efficacy1
- Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application1
- Orange Book: questions and answers1