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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
Indian generics maker Ranbaxy will pay $2.3 million for selling drugs in Oregon that were manufactured in violation of current good manufacturing practices. 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
The French National Assembly this week approved a proposal that would allow doctors to use less expensive off-label drugs even if an approved therapy exists, a move that drew immediate criticism from Europe’s pharmaceutical industry for placing cost savings over patient safety. Read More
Not all clinical trials need to be registered on clinicaltrials.gov, so sponsors need to understand the specific elements that determine if their trial is applicable to those reporting requirements, an expert says. Read More
Makers of drugs to treat opioid-induced constipation need not conduct further large, long-term cardiovascular outcomes safety trials, an FDA advisory panel tenuously concluded June 12, noting that it may be wiser to require postmarket observational studies. Read More