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Focus on Regulation

Tag Archives: untitled letter

FDA Shuts Down OTC Drug Manufacturer with Longstanding and Pervasive cGMP and Labeling Issues

On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good Manufacturing Practice (cGMP) requirements and for failing to include required labeling.  Under the 24-page decree, a federal court enjoined the defendants,

OPDP Issues Another Enforcement Letter Aimed at Preapproval Promotion

The Food and Administration’s (FDA’s) Office of Prescription Drug Promotion (“OPDP”) issued an enforcement letter to CBA Research, Inc., on April 25, 2013 regarding improper promotion of its investigational new drug CBT-1® (tetrandrine) Capsule (“CBT-1”).  According to OPDP, the company’s website misleadingly promoted the investigational new drug as safe and effective and  overstated its efficacy.