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Companies need to know how to access their archives — day or night — when using a third party for document storage and preparing for an FDA inspection, an FDA inspections expert advised at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More
Sponsors of programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies for cancer can now request approval for intravenous dosing regimens that weren’t included in the pivotal trials or earlier developmental studies, the FDA said in a final guidance released yesterday. Read More
A new guideline from the International Council for Harmonization (ICH) promotes the use of a continuous manufacturing (CM) process that can lead to shorter production times, a reduced risk of human error and an increase in quality. Read More
Reducing the collection of safety data in late-stage and postapproval clinical trials can improve trial efficiency, the FDA says in a final guidance published on Monday. Read More
President Biden has signed into law a bill that creates a new registration process for carrying out marijuana-related research and for facilitating the development and manufacturing of marijuana-based drugs. Read More
The FDA should take a page out of one online retail giant’s book, says Commissioner Robert Califf, as it works to update its technology infrastructure and make its processes and interactions with industry as efficient as possible. Read More