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The FDA has issued new recommendations on pediatric drug trials, issuing a draft guidance on inflammatory bowel disease (IBD) drug development and a final guidance on extrapolating partial onset seizure (POS) drug efficacy from adults to patients one month and up. Read More
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 of PTSD and veteran suicide. Read More
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 and Related Biological Products Advisory Committee (VRBPAC). Read More
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 that application. Read More
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 and accelerated approval for Epkinly. Read More
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. Read More
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 charging — removing them from where they are used or sold. Read More
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. Read More
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 and regulations that could impact your business. Read More
The FDA has called out three drugmakers for lack of compliance with current good manufacturing practices (cGMP) and marketing unapproved products, among other lapses. Read More
AdvaMed commended CMS for its July 10 proposed rule that includes separate payments for diagnostic radiopharmaceuticals are used to diagnose and treat diseases such as Alzheimer’s and cancer. Read More
A Texas pharmaceutical marketer was sentenced to two years and five months in federal prison and ordered to pay over $59 million in restitution for conspiring to defraud the US, receiving illegal kickbacks in exchange for compounded medications prescription referrals, and money laundering. Read More