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The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Read More
The European Medicines Agency hit a snag in its efforts to publish clinical trial data reports, due to long pilot phases for the first publications it made after the policy took effect last October. Read More
The European Medicines Agency stands to lose nearly one-fifth of its staff when it leaves London, no matter which city in the European Union is selected for its new headquarters, a survey of the EMA workforce showed. Read More
CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More
Developers of antiviral drugs for prophylaxis and treatment of respiratory syncytial virus should expose at least 100 adults in clinical trials ahead of pediatric studies, the FDA said in new guidance for drugmakers. Read More
Rigorous patient preference information should be part of the FDA’s process to determine risks and benefits of new products, Commissioner Scott Gottlieb said in a statement coinciding with the inaugural meeting of a new advisory committee on patient engagement. Read More