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A group of 28 Republican lawmakers is adding to the avalanche of opposition to the FDA’s proposed generic drug safety labeling rule, saying it will sow confusion and increase drug costs. Read More
If an EU nation finds a safety issue with a drug and flags it for review, that decision will start a 60-day clock during which a drugmaker will have the opportunity to resolve all concerns about the product or face revocation or modifications to its market authorization. Read More
Drugmakers should routinely assess the effectiveness of “dear healthcare provider” letters that provide updated safety or usage information about a drug and make improvements where needed, the FDA said Wednesday. Read More
FDA reviewers have unveiled the top five reasons for drug approval delays and denials over a twelve-year period, noting that many could be avoided if drugmakers submitted more accurate and useful information. Read More
The FDA is continuing its efforts to improve the ANDA approval process, this time asking generics makers to provide comments on what elements of the process are creating stumbling blocks and how the agency can help clear them away. Read More
Amag Pharmaceuticals’ regulatory woes deepened Wednesday as its bid to seek a new indication for its flagship iron deficiency drug Feraheme was rejected by FDA reviewers. Read More
The European Medicines Agency authorized 81 drugs in 2013, a 42 percent increase over the number of marketing authorizations in 2012, the agency reported Monday. Read More
Proposed international guidelines on metal impurities in finished drugs may be impossible to meet because they lack specificity and are impractical for suppliers, drugmakers say. Read More
Boehringer Ingelheim is halting development of deleobuvir-containing hepatitis C (HCV) drugs after Phase III clinical trial data showed the candidate lacked therapeutic value, clearing away one more candidate from the crowded field of new HCV treatments. Read More
Brand drugmakers are denying accusations they’re behind a covert campaign to block proposed patent law changes that would improve access to generics in South Africa. Read More