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Drugmakers that market products in Brazil have two years to present Anvisa with a full report of traceability of at least three batches, according to a resolution published in the Dec. 11 Official Journal. Read More
EU lawmakers last month approved a compromise proposal for a new clinical trials regulation, paving the way for a March 10 plenary debate and adoption of a single regulatory framework for all 28 member states before upcoming May elections. Read More
At least 75 percent of clinical trials are extended by six weeks or more because of failure to enroll enough patients, a new study finds, but help may be on the way in the form of “big data.” Read More
Merck’s blood thinner vorapaxar appears headed for the regulatory finish line after years of clinical hiccups, securing a 10-1 vote in favor of approval from an FDA advisory panel Wednesday. Read More
The FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet went into effect Tuesday, and the agency will soon begin withdrawing approvals for products made by companies defying the ban. Read More
State governments are continuing their push to regulate compounding pharmacies, placing tighter restrictions on those compounders who stay out from under the voluntary regulations imposed by the Drug Quality and Security Act. Read More
The FDA’s budget for 2014 is coming into focus as House and Senate appropriators Jan. 13 approved a $1 trillion omnibus bill that will set the agency’s budget at $4.35 billion, an increase of $91 million from 2013, House appropriators say. Read More
Chelsea Therapeutics’ second encounter with an FDA advisory panel over its blood pressure drug Northera has garnered an even stronger positive nod than a 2012 vote that resulted in a surprise complete response letter. Read More
The FDA’s budget for 2014 is coming into focus as House and Senate appropriators late Monday approved a $1 trillion omnibus bill that will set the agency’s budget at $4.35 billion, an increase of $91 million from 2013, House appropriators say. Read More