Tissue Agnostic Drug Development in Oncology
This guidance describes the development of tissue agnostic drugs, scientific considerations in determining when tissue agnostic oncology drug development may…
Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request…
Institutional Review Board (IRB) Written Procedures
Guidance for institutions and IRBs on IRB written procedures
Evaluation of Sex Differences in Clinical Investigations
Evaluation of Sex Differences in Clinical Investigations – IRB Information Sheet
Robust Detection of Ecstasy‐Like and Adulterants Through ASAP‐MS and DD‐SIMCA
The following graphical abstract presents the chemometric analysis applied to ASAP-MS data for the classification of ecstasy samples and their…
S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
International Council on Harmonisation – Safety
E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers
International Council on Harmonisation – Efficacy
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention
Clinical / Medical
FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions
Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND; Frequently Asked Questions