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The FDA served Alkermes with a warning letter for serious violations in the promotion of its opioid addiction treatment Vivitrol (naltrexone for extended-release injectable suspension). Read More
Two dozen states are urging Purdue Pharma to consider specific actions to protect OxyContin patients, including discontinuing the 80 mg OxyContin dose. Read More
Focusing on a new GAO report, a House subcommittee pressed CDER Director Janet Woodcock yesterday on “persistent challenges” facing the FDA’s foreign inspections, which include understaffing, unreliable translations and giving advance notice of inspections. Read More
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted eleven to two yesterday not to recommend approval of Correvio International’s NDA for vernakalant hydrochloride solution for treatment of recent onset atrial fibrillation. Read More
The Senate voted 91-2 on Tuesday to approve legislation that reforms the FDA’s over-the-counter (OTC) monograph system. A companion bill in the House has been introduced but no hearings have been held. Read More