JD Supra8h
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
JD Supra3d
Navigating FDA from 2024 into 2025 Human Foods Program
FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food ...
pharmaphorum1d
The FDA’s Guidance on Labels and Cartons: yet another attack on pharmaceutical trade dress?
The FDA closed the comment period for the draft Guidance on June 24, 2013 and is actively reviewing the submissions by numerous groups, including PhRMA. There is currently no set deadline by which ...
STAT25d
FDA’s new guidance on AI in drug development centers the risk introduced by the technology
The FDA’s new draft guidance comes on the heels of a reflection paper from the European Medicines Agency on the use of AI in the drug product lifecycle, finalized in September 2024.
policymed.com6d
Final FDA SIUU Guidance: Understanding the Key Updates and Resources
In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on ...
Hosted on MSN23d
FDA kicks off new year with draft guidance on skin biopsies in trials
The US Food and Drug Administration has issued guidance urging sponsors and trial sites to consider the necessity of the invasive procedure and gaining assent and consent from children ahead of trials ...
US FDA drops web pages on improving clinical trial diversity
The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...
Nature1mon
FDA transgenic animal guidance finally surfaces
After a decade of delays and procrastination, the US Food and Drug Administration (FDA) has finally issued a draft guidance describing how it plans to regulate the commercial use of genetically ...