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Strengthening and exploring additional uses of the FDA’s Sentinel System will be a top priority of PDUFA VI, agency officials said during a Wednesday public meeting to kick off negotiations on reauthorization of the Prescription Drug User Fee Act. Read More
Mylan is continuing its recall of 14 lots of calcium chloride prefilled syringes that are incompatible with certain needleless adaptors, issuing a second letter in June after learning the product may still be on the market. Read More
Generics manufacturer Amphastar Pharmaceuticals was silenced by a federal judge in California over its latest whistleblower lawsuit in a 12-year battle over Sanofi’s blockbuster anticoagulant Lovenox. Read More
A Johnson & Johnson factory that closed in 2010 after being at the center of massive recalls of over-the-counter products is close to reopening, the company said Tuesday. Read More
The FDA and its European counterpart will establish a joint patient engagement working group to share best practices on involving patients in drug development and monitoring. Read More
The FDA has banned all imports from Emcure Pharmaceuticals’ Hinjewadi, Maharashtra, India, facility due to current good manufacturing practice violations, making it the latest in a growing list of Indian firms facing agency action. Read More
Reports of adverse drug reactions in China rose by less than 1 percent last year, compared with 2013, with injectables showing the biggest increase, data released by the China Food and Drug Administration shows. Read More