Bleeding rates associated with new use of dabigatran (Pradaxa, Boehringer Ingelheim) do not appear to be higher than bleeding rates associated with new use of warfarin, according to an FDA safety review of post-market reports of serious bleeding events.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.