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Titles
- ANDA submissions--amendments to abbreviated new drug applications under GDUFA1
- Adaptive designs for clinical trials of drugs and biologics1
- 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
- COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators1
- Chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)1
- Competitive generic therapies1
- Determining whether to submit an ANDA or a 505(b)(2) application1
- Elemental impurities in drug products1
- 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
- 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
- Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment1
- How to prepare a pre-request for designation (pre-RFD)1
- Human gene therapy for retinal disorders1
- Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination1
- M4E(R2): the CTD--efficacy1