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The FDA says someone hacked into CBER’s online submission system last month and may have put users in danger of having their online personal identity stolen. Read More
Drugmakers have 13 months to revamp how they track drugs after the Senate voted Nov. 18 to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
The European Commission (EC) is threatening to take legal action against Italy, Poland, Slovenia and Finland for failing to implement the Falsified Medicines Directive, an EU-wide anti-counterfeit initiative that has been in effect since Jan. 2, 2013. Read More
Drugmakers that face multiple disputes with doctors over payments reported to the Centers for Medicaid and Medicare Services (CMS) under the Physician Payment Sunshine Act will likely face an audit by the agency. Read More
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee strongly urged approval of BioMarin’s orphan drug Vimizim to treat the rare disease Mucopolysaccharidosis Type IVA, overriding agency concerns of limited supportive data. Read More
Chinese authorities are gearing up to keep the cost of certain drugs sold in the country down via publication of a “low-cost” drug list expected to expand access to generics. Read More
A California judge has ruled that Sandoz must file an application with the FDA for approval of a biosimilar referencing Amgen’s biologic arthritis drug Enbrel before it can challenge the brand drug’s patents. Read More
Drugmakers are pushing back on proposed EU GMP requirements that would expand safeguards against product cross-contamination, saying the proposed six-month timeline for implementation is unworkable. Read More
Sanofi has decided to stop pursuing regulatory filing for its blood cancer drug fedratinib after new safety concerns arose from several clinical trials. Read More
A drug’s active ingredient name does not need to appear every time its brand name is repeated in an advertisement, the FDA says, clarifying the most common advertising issue that drugmakers question the agency about. Read More
The FDA says developers of next-generation heart drugs, known as PCSK9 inhibitors, will need to present data showing only their effectiveness at lowering cholesterol, blood pressure and inflammation, not reducing heart attack or stroke. Read More