FDA Releases Guidance on Communication with the Agency

FDA released draft guidance on Dec. 4, 2015 on the agency’s recommendations for best practices in communication between investigational new drug application (IND) sponsors and FDA during drug development. The guidance provides FDA’s expectations for methods of communication and timing of FDA responses to IND sponsor inquiries. It also details the types of advice and interactions that are appropriate between IND sponsors and FDA review teams.

The guidance does not apply to communications between FDA and industry trade organizations, consumer advocacy groups, other government agencies, or non-IND stakeholders. FDA states that the guidance will be updated as communication practices evolve.

Source: FDA