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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
The Therapeutic Goods Administration is considering adopting 15 EU guidelines relating to drug development, including guidance on biosimilars, lipid disorder therapies and bacterial infections. 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
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
The European Medicines Agency acted properly in rejecting a UK-based pharmaceutical company’s over-the-counter migraine medicine, the European ombudsman says. Read More
The generic drug industry wants the FDA to ensure new requirements for packaging and technologies aimed at curbing opioid abuse don’t result in barriers to market entry for generic makers. Read More
European drugmakers are praising the European Commission’s plans to increase enforcement of intellectual property rights in the EU and developing world over the next two years, saying they are important to ensuring EU innovation and economic competitiveness. Read More