Lisa Dwyer

Since taking the reins as FDA Commissioner, Dr. Martin Makary has repeatedly expressed an interest in new regulatory pathways, or new options for evidence generation, that would enable more flexible FDA review of...more On Tuesday, September 9, the U.S. Food and Drug Administration (FDA) issued a press release announcing “sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements,” while simultaneously sending a...more The House Committee on Appropriations approved legislation that would prohibit the production, distribution, and sale of hemp-derived delta-9 tetrahydrocannabinol (“THC”) and related cannabinoids at the federal level. If the...more On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more