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India’s national drugs authority will hire 147 inspectors this year to ensure adherence to good manufacturing practices, but training will determine success, an observer says. Read More
Just as the U.S. Food and Drug Administration is ramping up inspections in China, Chinese regulators are increasing their oversight of overseas manufacturing operations, conducting 30 inspections so far in 2015. Read More
AstraZeneca has sold global rights, excluding the U.S., to its Entocort gastroenterology drug to Tillotts Pharma for $215 million, as it focuses on cancer and diabetes therapies. Read More
The FDA’s Office of Prescription Drug Promotion has warned Herndon, Va., drugmaker ASCEND Therapeutics US for distributing promotional cards about its EstroGel product that omit important risk information. Read More
Bipartisan leaders of the House Energy & Commerce Committee are asking the FDA why extended-release opioids require black box warnings and immediate-release versions of the painkillers do not. Read More
A study of nearly 28,000 women linked antidepressants Paxil and Prozac to a small increase in birth defects, but cleared three other antidepressants of such concerns. Read More
The FDA is requiring stronger label warnings for non-aspirin nonsteroidal anti-inflammatory drugs, after a comprehensive review of new safety information affirmed an increased risk of heart attack or stroke. Read More