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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
Sponsors hoping to use equivalence criteria in analyzing bioequivalence (BE) studies for their drug applications just got more details on how the FDA wants them to undertake that. Read More
The European Medicines Agency (EMA)’s safety committee has recommended withdrawing medications containing pholcodine, an opioid active ingredient used alone or in combination with other substances, to treat dry cough, cold and flu symptoms. Read More
The most challenging drug shortages the U.S. faces are not the new ones that crop up from illnesses like COVID-19 or the current spike in respiratory illnesses. Rather, the shortages that have been ongoing for years cause the FDA the most strife. Read More