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Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

Ranbaxy Labs Gets A Sweeping Consent Decree (01/25/12)

February 1, 2012 By Barry Friedman Leave a Comment

RANBAXY REQUIRED TO PAY $500 MILLION FINE COMMENT Ranbaxy Laboratories entered into a Consent Decree with the FDA on January 25, 2012 wherein they agreed to pay a $500 million fine and accept changes to plants both within the US and India.  This Blog has previously reported on a number of on-going issues to include the falsification of data … [Read more...]

Johnson & Johnson McNeil-PPC Consent Decree and Permanent Injunction

March 15, 2011 By Barry Friedman Leave a Comment

Johnson & Johnson McNeil-PPC Consent Decree and Permanent Injunction Comment The recent Consent Decree and Permanent Injunction against McNeil-PPC and two of its Vice Presidents recalled an article from March 2010 re: "FDA Recommends Increased Criminal Prosecutions of Responsible Corporate Officials...".  The initial paragraph is enclosed below.  … [Read more...]

Permanent Injunction Deltex Pharmaceuticals January 18, 2011

January 29, 2011 By Barry Friedman Leave a Comment

Federal Government obtains permanent injunction against Deltex Pharmaceuticals Inc. Company charged with manufacturing and distributing drugs in violation of federal law The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against … [Read more...]

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