The black eye the FDA received recently over its handling of Vioxx (rofecoxib, Merck) and antidepressants hasn't slowed the agency's new drug approval rate for 2004. It cleared 31 new molecular entities (NMEs) last year, up from 21 in 2003.
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.