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DoJ and GMPs: A Prosecutor’s Take on Enforcing Product Quality

This article was originally published in RPM Report

Executive Summary

The wave of marketing promotions undertaken by the Department of Justice over the past decade may be abating, but prosecutors are looking at manufacturing violations as fertile new territory for cases. One prosecutor shares her thoughts on how companies can protect themselves.

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FDA’s Call for Quality: Revamped GMP Initiative Stresses Cost Savings

FDA is kicking off phase two of its 21st Century GMP initiative using new authorities and funding under the FDA Safety & Innovation Act. To encourage investment in quality manufacturing systems, the agency is highlighting the cost savings seen by early adopters of quality systems..

FDA’s Call for Quality: Revamped GMP Initiative Stresses Cost Savings

FDA is kicking off phase two of its 21st Century GMP initiative using new authorities and funding under the FDA Safety & Innovation Act. To encourage investment in quality manufacturing systems, the agency is highlighting the cost savings seen by early adopters of quality systems. And if that’s not incentive enough, FDA has already shown it is quite willing to use the new enforcement authorities. Ranbaxy is a case in point.

Are GMP Violations The “Next Hot Thing” In False Claims Act Litigation?

Former prosecutors say there are cases pending under seal, but it is uncertain whether the government will intervene. They note the difficulty in proving the allegations and say FDA’s regulatory regime may be a better route for handling GMP issues.

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