FDA provided an update on the implementation of new accelerated approval authorities and emphasized that drugs approved under the pathway meet efficacy requirements.
The upcoming election, and the approaching end of the President's four-year term, introduce additional dynamics into the agencies' rulemaking process and even the guidance process.
Welcome to the next installment of Arnold & Porter's Virtual and Digital Health Digest. This edition primarily covers March 2023 highlights across the virtual and digital health space.
On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act for 2023, colloquially referred to as the omnibus funding bill, that includes a similarly expansive.