FDA recently announced several new guidance documents that may be of interest to clinical investigators as well as administrators.
- Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information
Agency recommendations for trials with live biologic products in support of an IND
- E7 Studies in Support of Special Populations: Geriatrics; Questions and Answers
Q&A for trials of drugs likely to have significant use in elderly populations
- Drug Interaction Studies—Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations
Draft guidance on designing studies to support new drug applications and biologics license applications
- Providing Submissions in Electronic Format — Standardized Study Data
Draft guidance on submission of data to FDA using a standard electronic format
