Eva Temkin to Speak at Food and Drug Law Institute

Washington, D.C. FDA and Life Sciences partner Eva Temkin will be a moderator at the Food and Drug Law Institute (FDLI) Navigating the Accelerated Approval Pathway: Promotional Strategy conference in Washington, D.C. on Nov. 3. This will cover “Navigating the Accelerated Approval Pathway: Promotional Strategy.”

Under 21 CFR § 314.550, applicants must submit to FDA all promotional materials, including promotional materials and advertisements, for dissemination or publication. This session will provide guidance to industry in structuring a promotional regulatory strategy when seeking accelerated approval pathways. Panelists will share best practices from pre submission through post-approval, including collaboration with marketing.