FDA will require applicants to include an additional certification form not mentioned during the public meeting on March 2, 2011.

We wish to call your attention to a requirement for submittal of a certification form to FDA with drug applications which was not mentioned at the March 2, 2011 FDA meeting or elsewhere in guidance FDA has provided on PET applications, nor on the application check list. Thanks to Jim Slater at UCSF for calling this to our attention. Jim learned of this requirement in a conversation with Martin Shimer at OGD.

View the certification form (FDA 3674) and an FDA guidance which describes what types of applications require this certification form to accompany the submission.