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An updated version of the Biosecure Act gives US businesses until 2032 to decouple from four Chinese biotech companies identified as being of “particular concern” over data mining on behalf of the Chinese government. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
This week, the FDA announced its final rule for laboratory developed tests. Draft guidances were published on enforcement policies for tests during a Section 564 declared emergency, IVD enforcement policy in the absence of a Section 564 emergency declaration and a REMS logic model. Advisory committee meetings were announced for Donanemab, Lilly’s Alzheimer’s drug and for Midomafetamine capsules. Read More
The Department of Justice (DOJ) has formed a new enforcement arm — the Task Force Health Care Monopolies and Collusion (HCMC) — to guide the department’s policy approach for healthcare, but also to pursue investigations as well as civil and criminal enforcement in healthcare. Read More
The FDA has joined forces with the Environmental Protection Agency (EPA) and the Department of Agriculture (USDA) on a plan to regulate genetically modified organisms and biotechnology products for humans. Read More
The FDA and NIH are asking stakeholders for support in developing a glossary of terms related to clinical trial innovation especially for terms involving real world data (RWD) and real world evidence (RWE). Read More
A major agency-wide reorganization affecting regulatory affairs and medical products, and more than $12 million to tackle supply chain issues across all products areas, were included in the FDA’s FY 2025 budget proposed to a Senate Appropriations subcommittee Wednesday morning by Commissioner Robert Califf. Read More
After enduring several setbacks, Lilly will pitch its antiamyloid contender donanemab to the Peripheral and Central Nervous System Advisory Committee in a June 10 meeting. Read More