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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
Just months after launching its new cholesterol combo drug Liptruzet, Merck is recalling all of the drug that hasn’t already reached customers because of concerns that defective packaging could decrease its potency. Read More
Compounding pharmacies registering with the FDA for oversight are being drawn to the federal regulator by the appeal of knowing they meet the highest quality standards and to free themselves from complex and varied state laws. 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