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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
Drug distributors are suing Barr Pharmaceuticals and Boehringer Ingelheim (BI), alleging in a class-action complaint that the drugmakers crafted a $120 million pay-for-delay deal to keep a generic version of BI’s stroke drug Aggrenox off the market until at least July 2015. Read More
Generic drugmakers are pushing back against proposed new tight deadlines for responding to FDA questions about ANDAs, and the industry also wants the agency to show greater leniency in dealing with deficiencies in applications. Read More
Generic and brand drugmakers are urging the FDA to drop plans to require them to report manufacturing stoppages expected to result in shortages within five days of the stoppage occurring. Read More
The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More