FDA has announced broad reaching initiatives to update the 510(k) program and leverage international practices and requirements. This brings real opportunities for international firms to make much greater use of their non-US regulatory data to gain FDA approvals.
Join T.J. Thiel and Jean Nicolas Boudaud to provide guidance in navigating the FDA’s submission process uses your company’s international regulatory work. T.J. and Jean will discuss the numerous pathways for FDA approval as well as how these relate to the international (including TGA, Health Canada and EU) regulatory activities. This webinar will help understand the current synergies but also focus on the opportunities for harmonization.