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They include revisions to GMPs for raw ingredients and finished products, changes in annual IND reporting, and requirements for new, clearer labeling for patients in medication guides. Read More
An FDA advisory committee voted 12-to-1 against recommending approval of Janssen’s Plivensia (sirukumab) in treating rheumatoid arthritis, saying its safety profile raised too many concerns. Read More
A California company violated federal law by making and selling as a dietary supplement a product containing prescription drugs used to treat erectile dysfunction, the FDA said. Read More
The European Medicines Agency developed a continuity plan to handle the workload linked to the UK’s withdrawal from the European Union and the relocation of the EMA’s headquarters. Read More