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The EMA is trying to simplify data integrity compliance by compiling all of its expectations into a single document that covers the entire data integrity lifecycle. Read More
Nearly two years after the agency said that it would review its regulatory framework on off-label use, the FDA announced that it would hold a meeting Nov. 9 and 10 to involve stakeholders in the framing of guidance and regulations on unapproved uses. Read More
Drug safety label information will be available closer to its approval date now that CDER’s Office of Communications is handling label changes, CDER Director Janet Woodcock announced Thursday. Read More