SUBSCRIBE

Breaking News on Contract Research, Manufacturing & Clinical Trials

Service Sectors > Regulatory affairs

FDA group calls for industry to submit draft guidance docs

By Nick Taylor , 04-Jan-2012

The FDA should encourage industry to submit draft guidance to speed regulatory development, an agency working group found.

Urging industry to submit draft guidance proposals to the US Food and Drug Administration (FDA) is intended to further the President Obama-backed transparency push and streamline new regulation.

[FDA Centers and Offices] should encourage stakeholders to submit draft guidance for consideration if such drafts would help advance understanding of a particular issue”, an agency working group on good guidance practices (GGP) wrote.

GGP regulation at the FDA allows for stakeholders to send drafts of proposed guidance but it is more common for industry to informally identify topics in need of the agency’s attention. However, teams at the FDA are now encouraging submission of draft guidance at industry events and online.

Submitting draft guidance, rather than guidance topics, enables the [FDA] to approach a guidance topic with a better understanding of the issues that interest the stakeholder”, the group wrote. The working group thinks this can speed guidance development, particularly in novel scientific fields.

Industry communication

Clarification of the annual guidance agenda is needed, the working group found. Each team at the FDA has different standards for deciding which guidance documents are listed and harmonising the process will make industry better informed.

Giving companies a clear idea of planned guidance documents could stimulate industry input. Other working group strategies to promote communication include descriptions of how industry can give advice to the FDA.

Sharing guidance

The FDA transparency initiative also calls for better communication of published guidance. This week the FDA redesigned its website, making guidance documents easier to find, and the working group wants to push the shift to online further.

FDA should revise the GGP regulation to require the agency to publish the annual guidance agenda on the internet only. Eliminating the Federal Register publication requirement would reduce the agency’s burden and increase efficiency”, the working group wrote.

Related products

Key Industry Events

 

Access all events listing

Our events, Events from partners...