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The European Commission will revise four sections of its good manufacturing practice guideline and add a new one, as it moves to harmonize GMPs with international standards and speed the path to mutual reliance with foreign regulators, a UK official says. Read More
The U.S. Food and Drug Administration expects to boost its China office staff to 35 within the next two years and its India staff to 23 as the agency focuses on increasing inspections in both countries. Read More
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