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The agency said sponsors should take any necessary additional steps ahead of pediatric studies, depending on nonclinical pharmacology and toxicology findings observed in adults. Read More
Rather than replacing relationships between the FDA’s product centers and patient organizations, the committee aims to expand those connections. Read More
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