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Drugmakers in the EU must create a program to assess the effectiveness of their risk minimization efforts for each marketed drug, EU regulators say. Read More
The FDA and the European Medicines Agency (EMA) have completed their analysis of study data on incretin-based type 2 diabetes drugs and conclude they do not increase the risk for pancreatitis or pancreatic cancer. Read More
New authorities granted to the FDA in 2012 that stiffened penalties for drug counterfeiters are failing to curb the problem of fake drugs because they do not apply to distributors of counterfeits. Read More
As calls for revoking the FDA’s approval of Zogenix’s painkiller Zohydro ER continue to grow, lawmakers are now questioning whether a public-private industry partnership tainted the agency approval process. Read More
FDA advisors want stronger warning language on labels for non-steroidal anti-inflammatory drugs, or NSAIDs, saying language added in 2005 is not strong enough and may lead doctors and patients to think there is no risk of cardiovascular (CV) blood clots in short term use of the drugs. Read More
After fielding nothing but complaints with its proposed generic drug safety labeling rule, the FDA is receiving rare support for the proposal from a coalition of patient groups that says it would give injured consumers a clear avenue for redress. Read More
The FDA Tuesday released new information that shows the scope of its efforts to investigate the efficacy and bioequivalence of generic drugs, publishing summaries of ongoing research. Read More
A congressional committee is reviving an investigation into the FDA’s surveillance of employee emails, and is asking agency officials what the FDA has done to protect whistleblowers from harassment. Read More
Endo Pharmaceuticals, as part of a $192.7 million settlement, has agreed to enter into a five-year corporate integrity agreement (CIA) with HHS to resolve marketing violations surrounding its painkiller Lidoderm. Read More
Republican House members introduce legislation to combat prescription drug abuse through partnerships between industry, retail and government. Read More