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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
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
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
The Centers for Medicare & Medicaid Services (CMS) plans to force makers of antidepressants and immunosuppressants to compete for inclusion on Medicare Part D formularies, which it hopes will compel drugmakers to lower prices, a possible boon for the generics industry. Read More
Highlighting a growing dispute in the pharmaceutical industry, Johnson & Johnson is arguing that biosimilars should have international non-proprietary names (INN) that are similar to, but distinguishable from, reference products. Read More