FDA Releases Guidance Documents on Risk Information and IND Applications

Published on: 

The agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients.


FDA has issued two guidance documents this week. The first, released on Feb. 4, 2014, is a draft guidance that describes Form FDA 3926, the Individual Patient Expanded Access-Investigational New Drug Application. FDA 3926 will be available for licensed physicians to use for expanded access requests for individual patient investigational new drug applications (INDs) and will provide an alternative to submitting an IND under 21 Code of Federal Regulations Part 312.23.  The guidance, however, is not applicable to other types of expanded access requests such as for medical devices.


The second guidance is a revised guidance that provides recommendations for disclosing risk information in consumer-directed advertisements and promotional labeling in print media for prescription medications. The revised draft is in response to stakeholder requests for guidance on disclosing risk information and describes “an alternative disclosure approach that FDA refers to as a consumer brief summary.” The guidance, however, “does not focus on the presentation of risk information in the main body of promotional labeling or advertisements and does not apply to promotional materials directed toward health care professionals.”

Source: FDA.gov.