FDA's new Rx label rule may limit lawsuits
The Food & Drug Administration has announced a new format for prescription drug labeling that will organize the most important information needed by healthcare providers in a more accessible and easy-to-read fashion, according to the agency. But what may have started as an effort to decrease the 300,000 preventable adverse drug events that occur each year, has led some groups to accuse the FDA of attempting to protect manufacturers from consumer liability suits.
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.
