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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
- Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice1
- Bioanalytical method validation1
- Elemental impurities in drug products1
- 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 dispute resolution: sponsor appeals above the division level : guidance for industry and review staff : good review practice1
- General principles for evaluating the abuse deterrence of generic solid oral opioid drug products1
- 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
- How to prepare a pre-request for designation (pre-RFD)1
- M4E(R2): the CTD--efficacy1
- Physiologically based pharmacokinetic analyses--format and content1
- Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications1
- Regulatory classification of pharmaceutical co-crystals1
- Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs1
- Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system1