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Compounding pharmacies are asking the FDA to overhaul its guidance for interim good manufacturing practices, contending the recommendations for such things as the cleanliness of air filters and presence of particulates are unclear and subjective. Read More
FDA officials sought to clarify how the agency’s authority to punish drugmakers for obstructing facility inspections applies to such issues as divulging trade secrets, accessing emails and translating documents into English. Read More
The FDA is honing in on roughly eight to 10 quality metrics that the agency plans to collect from drugmakers starting in 2015, and expects to publish a guidance that names them by the end of the year. Read More
Within two years, the FDA will begin assigning all facility inspections to specialized teams that have detailed expertise in the lifecycle of the particular drug that is subject to inspection. Read More
A Pennsylvania jury last week ruled that Takeda must pay more than $2 million for downplaying bladder cancer risks of its diabetes drug Actos, a verdict one legal expert believes could embolden other plaintiffs to move forward with their lawsuits. Read More
A European biotech association is calling on the European Union to develop policies addressing inconsistencies in the labeling and naming of biosimilars as a way to enhance the monitoring and acceptance of the growing body of products. Read More
The English government is considering halting reimbursement on costly cancer drugs, which officials concede could restrict patients from receiving certain treatments. Read More
Drugmakers seeking accelerated approval of a presurgical treatment for high-risk, early-stage breast cancer may consider conducting multiple trials rather than a traditional single trial, according to a new FDA guidance that aims to give sponsors an earlier indication as to the success of a drug candidate. Read More
A federal judge has dismissed to a local court a lawsuit alleging AstraZeneca negotiated illegal pay-for-delay settlements with generic firms to keep versions of its heartburn drug Nexium off the market.
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