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Dec. 11, 2019

Vol. 18
No. 238


Senate Advances OTC Monograph Reform Legislation

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

Advisory Committee Rejects NDA for Atrial Fibrillation Treatment

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

Lawmakers Press CDER’s Woodcock on Foreign Inspections

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

N.J. Drugmaker Warned for Quality Complaint Handling, Other Slipups

Teligent Pharma of Buena, N.J. was hit with an FDA warning letter for its handling of product quality complaints, among other violations. Read More