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After assessing its response to a recall in April, Health Canada is considering requiring drugmakers to notify the agency about emerging risks of marketed drugs before initiating recalls. Read More
Congress rejected the FDA’s call for mandatory oversight of compounding pharmacies, passing legislation Nov. 18 that instead allows compounders to volunteer for agency oversight. Read More
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
Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. 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
US WorldMeds, a specialty drugmaker, has been issued a warning letter from the FDA, noting false claims and omitted risk information for the company’s drug Revonto. Read More
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