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Last year was a productive one for the FDA’s CDER, which approved 45 novel drugs — an increase from its 2006 to 2014 average of 28, according to the agency’s 2015 Novel New Drugs Summary released Monday. Read More
The FDA has underestimated the burden that would be imposed on drug manufacturers in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance. Read More
The Italian Medicines Agency has issued a noncompliance statement to Rome-based radiopharmaceutical maker Iason Italia, hitting the company over deficiencies primarily related to sterility assurance. Read More
A Los Angeles area supplement provider has been hit with an FDA warning letter for selling unapproved drugs for conditions ranging from kidney stones to stroke prevention. Read More
Dr. Reddy’s Laboratories has adopted a unique strategy to bypass legal issues surrounding its generic version of Nexium: changing the color of its capsules. Read More