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The FDA found serious violations at Sun Pharma’s Halol, Gujarat facility in an inspection earlier this month, hitting the company with a Form 483 for issues ranging from data integrity to employee training. Read More
The approval of Novartis’ novel gene therapy Zolgensma was one of CBER’s major achievements in fiscal 2019, according to center Director Peter Marks. Read More
Correvio Pharma drew a complete response letter from the FDA for its atrial fibrillation treatment Brinavess (vernakalant) because of inadequate safety data. Read More