Latest from Bridget Silverman
US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.
Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.