How does TPD/BGTD decide to proceed with guidance development?
When an issue is identified, a Project Lead will be identified and an issue analysis will be conducted to determine the most appropriate way to deal with the issue. Options could include a regulatory change, the development of a guidance document, the development of a communications or risk management piece (e.g. a Notice to Stakeholders, a Dear Healthcare Professional Letter, etc.), or no action. The result of the issue analysis will be an Issue Analysis Summary (IAS), which may be published on the website for consultation. It is reasonable to assume that the issue analysis associated with a detailed, scientific guidance document may be more straightforward than that associated with broader, more complex issues dealing with multiple areas of expertise.
