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This week, the FDA published final guidance on drugs for treatment of partial onset seizures, combination product user fees, radiolabeled mass balance study clinical pharmacology considerations. Draft guidance was issued on pediatric inflammatory bowel disease. The agency also announced interactive site tours of biotechnology manufacturing facilities developing cellular and gene therapies. Read More
The FDA has sent an additional warning letter to China-based Jiangsu Shenli Medical Production for quality system violations for its enteral syringe products and expanded the company’s import alert to prevent their enteral syringes from entering the US. Read More
In this edition, we note the release of the EU’s highly anticipated AI Act, new reporting requirements for expected interruptions in the supply of medical devices or diagnostics and new guidance on IVD classifications. Read More
Baxter International has issued an urgent medical device recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly as there is a risk of the device becoming disconnected, resulting in loss of ventilation. 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
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
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 and 510(k) submissions for dental composite resins and dental curing lights. Read More