FDA Approvals - FDA Imposes Restrictions On Coast IRB Due To Violations (Medical
FDA Imposes Restrictions On Coast IRB Due To Violations (Medical News Today)
The U.S Food and Drug Administration announced that Coast IRB, LLC of Colorado Springs, Colo., has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human subjects participating in clinical trials.
FDA Obtains Permanent Injunction Barring Two Companies From Manufacturing And Distributing Unapproved Drugs (Medical News Today)
The U.S. Food and Drug Administration announced that it had obtained a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc. (Advent), of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs.