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Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research
This guidance provides information on the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA).
SPA is a process in which sponsors2 may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies3 (i.e., a Request for SPA (hereafter Request); see section III., Eligible Protocols and General Information) to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-1174.