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Titles
- Adaptive designs for clinical trials of drugs and biologics1
- Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters1
- 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
- Clinical drug interaction studies: cytochrome P450 enzyme- and transporter-mediated drug interactions1
- Determining whether to submit an ANDA or a 505(b)(2) application1
- Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment1
- Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products1
- FDA oversight1
- 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
- Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment1
- Institutional review board (IRB) review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency: guidance for IRBs and clinical investigators1
- Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination1
- M4E(R2): the CTD--efficacy1
- National women's health action at the F.D.A. Sept. 20, 19941
- Slowly progressive, low-prevalence rare diseases with substrate deposition that result from single enzyme defects: providing evidence of effectiveness for replacement or corrective therapies1