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To provide a more unified approach in evaluating biosimilars, India’s Central Drugs Standard Control Organization is requiring sponsors to conduct equivalence, non-inferiority or comparability Phase 3 clinical trials. Read More
The World Health Organization is calling for stricter enforcement of private vaccine management regulations in China to mirror the tight controls the country has over its public vaccine distribution system. Read More
Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months. Read More
The FDA has unveiled enhanced warnings for opioid pain medications that will affect 141 generic and 87 innovative immediate-release opioid products, which account for roughly 90% of all prescription opioids. Read More