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The FDA is expanding the types of documents that drugmakers can distribute to physicians that discuss off-label drug uses, loosening its limits on clinical practice guidelines (CPGs) and medical textbooks. Read More
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
Amarin has sued the FDA, seeking five years of market exclusivity for its prescription fish oil drug Vascepa, which the agency last week granted only three years of exclusivity. 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
Endo Pharmaceuticals has entered into a five-year corporate integrity agreement with HHS to resolve marketing violations surrounding the Lidoderm patch, a popular painkiller. Read More
Generic drug giants Teva and Mylan are just some of the 13 companies tapped by the FDA to participate in its Secure Supply Chain Pilot Program, an initiative five years in the making that will grant the companies’ U.S. product imports expedited treatment. Read More
The China Food and Drug Administration is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More
A control laboratory testing facility in Mumbai, India, has come under fire from the FDA after a summer inspection last year raised serious concerns about the quality of drugs tested there. Read More