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Science & Regulatory

CHPA's Scott Melville and FDA's Dr. Janet Woodcock featured speakers at USP workshop

CHPA President and CEO Scott Melville and FDA's Director of the Center for Drug Evaluation and Research (CDER) Dr. Janet Woodcock were featured guest speakers at the USP's September 8-9, 2011, workshop, "Over-the-Counter Drug Substances and Drug Products." Below are interviews with both discussing this important endeavor:


 

The distribution of medicine in the United States is based on a two-class system: prescription and nonprescription medicines. A nonprescription, or over-the-counter (OTC) drug is one that the U.S. Food and Drug Administration (FDA) has found to be safe and effective for direct consumer use based on the label instructions and warnings. FDA requires a wider margin of safety for nonprescription medicines than for prescription drugs.

Safe, effective, and widely available, OTC medicines play a vital and cost-effective role in our nation’s healthcare system. And CHPA and its members are committed to ensuring the science and quality of these important medicines.

Related links:

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Regulatory & Scientific Affairs Staff

Barbara A. Kochanowski, Ph.D.
Vice President,  Regulatory & Scientific Affairs

Marcia D. Howard, Ph.D.
Senior Director, Regulatory & Scientific Affairs

John S.  Punzi, Ph.D.
Director, Quality Assurance & Technical Affairs

Jay E. Sirois, Ph.D.
Director, Regulatory & Scientific Affairs