The FDA Drug Safety and Risk Management Advisory Committee voted 8 to 7 in favor of adding a black box warning to the labeling of all stimulant drugs used to treat ADHD. The group also voted unanimously (15-0) in support of requiring that FDA medication guides be distributed with each stimulant prescription, explaining the potential risks to patients and their families.
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.