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SAN DIEGO — The FDA is racing to beat a fall deadline to release a string of new guidances for generics makers that it hopes will head off a potential torrent of rejected submissions. Read More
French drugmaker Servier and five generics firms are facing roughly $580 million in fines from European antitrust regulators over an alleged pay-for-delay scheme. Read More
Drugmakers hoping to market generic and biosimilar products quickly in Brazil should pair up with the corresponding branded firms to facilitate the application process, says an updated rule that aims to speed generic approvals. Read More
The FDA has laid out new goals for speeding up its handling of regulatory submissions from generics makers that eventually call for 90 percent of some prior approval supplements to be acted on within six months and ANDA amendments to be acted on within 10 months. Read More
Massachusetts has become the eighth state to pass a law enabling pharmacists to substitute a biosimilar for a branded biological product, earning praise from industry groups that believe such state laws are vital to biosimilar adoption. Read More
The FDA would require biosimilars to carry the same name as their reference drug counterparts under a proposal being pushed by healthcare payers and GPhA. Read More
GPhA is stepping up its opposition to the FDA’s proposed generics labeling rule, releasing a survey that shows more than half of physicians, physician assistants and pharmacists would find the new system confusing for them and their patients. Read More
Top Republican lawmakers want the Obama administration to examine whether the FDA has the authority to impose a generic drug labeling rule, ratcheting up the rhetoric in an increasingly political battle over the controversial measure. Read More
Indian pharmaceutical authorities have enacted price controls on scores of branded-generic drugs to treat diabetes and cardiovascular disorders, a decision that one industry observer warns will also have a chilling effect on the introduction of patented drugs into the country as branded companies worry that price controls may soon come to their sector as well. Read More
Over the next four years, the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More