FDA Requests Info on Off-Label Product Uses, Products Not Legally Marked

The Food and Drug Administration (FDA) is announcing the establishment of a docket to assist with its evaluation of FDA policies on communications and activities related to (i) off-label uses of marketed products, and (ii) use of products that are not yet legally marketed for any use. The FDA states that it would like to obtain comments and information regarding scientific exchange about both unapproved new uses of products already legally marketed (“off-label” use) and use of products not yet legally marketed for any use.