FDA has approved Boston Therapeutic’s petition to file an Abbreviated New Drug Application (ANDA) for a new, chewable tablet formulation of the diabetes drug metformin hydrochloride. The company plans to market the new formulation under the name Pazamet.
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.