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

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. Source: Drug…

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,…

This week, the FDA published a final guidance on clinical considerations for studies of opioid use devices. Draft guidances were issued for misinformation about drugs and devices, use-related risk analyses…

Hamilton Medical has issued a recall for correction of the software in one of its ventilators, an issue that could cause the device to fail during procedures, a recall which…