The US Food and Drug Administration’s final rule on postmarketing safety reporting for combination products published on December 20, 2016. The FDA’s Office of Combination Products (OCP) presented a webinar on the rule on Friday, February 3, 2017, from 9 to 10 AM, Eastern Standard Time. OCP’s Associate Director for Policy, John Barlow Weiner, Esq., presented the rule, addressed agency plans and expectations relating to it, and responded to questions.
Recorded webinar link: https://collaboration.fda.gov/p30488putvk/?launcher=false&fcsContent=true&pbMode=normal
Webinar presentation: Final Rule on Postmarketing Safety Reporting