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Final Rules Regulation Risk Management

Mintz - Health Care Viewpoints

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more

Bergeson & Campbell, P.C.

TSCA Developments — A Conversation with Richard E. Engler, Ph.D.

This week, I discuss Toxic Substances Control Act (TSCA) developments with my colleague, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate. The U.S. Environmental...more

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