The FDA has issued new recommendations on pediatric drug trials, issuing a draft guidance on inflammatory bowel disease (IBD) drug development and a final guidance on extrapolating partial onset seizure…

Congressman Jack Bergman (R-Mich.) joined bipartisan lawmakers, veterans and post-traumatic stress disorder (PTSD) experts to highlight the need for FDA approval of midomafetamine (MDMA) -assisted therapy to address the treatment…

The FDA has opted to terminate CBER’s Allergenic Products Advisory Committee due to the expert group’s relative inactivity over the past few years, shifting its duties over to the Vaccines…

The FDA has issued final guidance on application fees for combination products, explaining that when a sponsor submits a single application for a combination product, the fee should be for…

This edition of Quick Notes focuses on congressional urging for approval of MDMA for PTSD and FDA approvals for J&J’s tuberculosis treatment Sirturo, a biosimilar for Eylea, a Stelara biosimilar…

New organizational changes in CDRH to strengthen and better position the Center to meet its mission to protect and promote the public health have been announced by the FDA. Source:…

Baxter is recalling the Life2000 Ventilator System due to the potential for failure of the battery charging dongle, which can prevent the system from charging or only allow for intermittent…

The FDA should “suspend” its implementation of the laboratory developed test (LDT) rule, the House Appropriations Committee said in its report on its deliberations on the FDA budget for 2025.…

As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws…

The FDA has called out three drugmakers for lack of compliance with current good manufacturing practices (cGMP) and marketing unapproved products, among other lapses. Source: Drug Industry Daily