The Generic Pharmaceutical Association (GPhA) called the approvalof Sandoz Pharmaceutical's Omnitrope human growth hormone (HGH) asignificant first step in bringing more affordablebiopharmaceuticals to the U.S. marketplace. GPhA president/CEOKathleen Jaeger said that FDA's Omnitrope decision demonstratesthat sound science exists to support the approval of genericbiopharmaceuticals.
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.