The FDA has published its proposed agenda for 2025 guidance, including new topics such as food colorings. Topics on the agenda are a priority for the Food and Drug Administration’s Human Foods Program ...
A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...
The FDA's removal of draft guidance on clinical trial diversity raises concerns about its commitment to diversity and compliance with statutory obligations. The draft guidance aimed to improve the ...
This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...
The FDA's Center for Devices and Radiological Health has been busy over the last couple of months, releasing several draft and final guidances that affect the makers of apps and connected devices.
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