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Two dozen states are urging Purdue Pharma to consider specific actions to protect OxyContin patients, including discontinuing the 80 mg OxyContin dose. Read More
“This unproven treatment could cause patients to forgo or delay FDA-approved treatments for opioid addiction and withdrawal,” the agency said. 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
Merck asked the court to rule that Accord’s generic infringes on the patent and to order that FDA not approve the planned product until after the patent’s expiration in 2026. Read More
Unapproved CBD products have not been evaluated for proper dosage, potential interactions with other FDA-approved drugs, or side effects, and the manufacturing process of unapproved CBD products has not been subjected to FDA review, she said. Read More