This webinar describes the information required by FDA to be submitted in a PMA annual report. The webinar also discusses FDA recommendations for level of detail the applicant should provide in the PMA annual report. Also addressed are the steps FDA staff generally takes when reviewing annual reports and the actions FDA may recommend after the annual report review. Also covered in this webinar are other reports – post-approval study reports.
A must attend webinar for those personnel that require an understanding of the FDA’s requirements for PMA annual reports.
Areas to be Covered:
Contents of a PMA Annual Report
Detail Required in an PMA Annual Report
FDA Review of PMA Annual Reports
Actions FDA May Recommend After PMA Annual Report Review
Post-Approval Study Reports
Interactive Q&A Session
Who will Benefit:
Regulatory Affairs Personnel
Clinical Research Associates
Personnel who require a general understanding of the FDA’s Requirements for PMA Annual Reports