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Titles
- Address Presented at the Festschrift to Honor Dr. Philip L. Calcagno, Washington, DC1
- Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters1
- Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations1
- Benefit-risk assessment for new drug and biological products: guidance for industry1
- 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
- FDA oversight1
- Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment1
- In development, new cancer medicines for older Americans1
- 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
- Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators1
- National women's health action at the F.D.A. Sept. 20, 19941
- Population pharmacokinetics1
- Real-time oncology review (RTOR): guidance for industry1
- Slowly progressive, low-prevalence rare diseases with substrate deposition that result from single enzyme defects: providing evidence of effectiveness for replacement or corrective therapies1