IND Submissions, Postmarket Safety Reporting on FDA Rulemaking Agenda for 2017

The FDA intends to publish a proposed rule that would replace current requirements for reports submitted on IND applications, according to an HHS inventory of agency rulemaking for 2017.

The upcoming rule, slated for publication in April 2017, would be generally consistent with global standards for the format, content and timing of the submission and is among several prospective actions on the FDA’s agenda for the new year.

In addition, the FDA expects to finalize a rule that would amend postmarket safety reporting regulations by August 2017. The rule, which has been in development since 2003, will include definitions of new terms and revise reporting deadlines.