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The FDA has asked Gilead Sciences to remove a sponsored link on Google that misrepresents the drugmaker’s hepatitis B drug, Viread, and omits risk information, the first such enforcement action since the agency issued guidance on character-limited advertisements last month. Read More
Manufacturer Hospira’s 2005 withdrawal of its leucovorin injection was not done for effectiveness or safety reasons, the FDA said, paving the way for new ANDAs on the generic anemia drug. Read More
The FDA released two major guidances for compounding pharmacies. One establishes for the first time an interim GMP framework for large compounders that register with the agency as outsourced facilities. Read More
The FDA warned another compounding pharmacy for mixing unapproved drugs and for poor quality, with Pharmacy Creations becoming the latest compounder to challenge agency enforcement of its activities. 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
A federal judge this week struck down Massachusetts’ recently enacted prescribing restrictions on Zogenix’s opioid painkiller Zohydro ER — restrictions that the drugmaker argued had effectively made the therapy unavailable and contravened the FDA’s right to approve drugs it considers safe and effective. 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
A European public-private partnership is launching a new $4.5 billion decade-long effort to improve the success rate of clinical trials on certain drugs by 30 percent and boost exclusivity to make manufacturing treatments more enticing. 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