Georgetown University’s Newspaper of Record since 1920

The Hoya

Georgetown University’s Newspaper of Record since 1920

The Hoya

Georgetown University’s Newspaper of Record since 1920

The Hoya

GU To Examine Expediting Drug Development in Jan. Workshops

Georgetown University’s Center for Drug Development Science (CDDS) is playing host to a workshop that will examine approaches for expediting drug development because Americans want safe and effective drugs brought to market as quickly as possible.

The workshop, titled “Confirmatory Evidence to Support a Single Clinical Trial as a Basis for Drug Approval,” will be held on Tues. 15 and Wed. 16. Congressman Richard Burr (R-N.C.), vice-chair of the House Energy & Commerce Committee, FDA officials and faculty from the CDDS will review a recent change in the Food, Drug and Cosmetics Act.

They will present congressional views on streamlining the drug review process. The conference will specifically address a section of the FDA Modernization Act of 1997 which allows approval of a new drug based on data from a single well-controlled clinical trial and sufficient “confirmatory evidence.” Another goal of this conference is to clarify the term “confirmatory evidence.”

In a press release, CDDS Director Carl Peck, M.D., professor of pharmacology and medicine and former director of the FDA Center for Drug Evaluation and Research said, “While there have been public discussions and debate among academic, industry and regulatory experts

about the meaning of `confirmatory evidence,’ there is no consensus yet.”

Peck also said the workshop seeks “to develop a report that outlines scientific qualities of confirmatory evidence that can credibly support approval of new drugs-with the ultimate goal being a more efficient and rapid process that provides assurance of effectiveness and safety.” Among the FDA officials to participate in the conference are CDER Director Janet Woodcock, .D.; Robert J. Temple, M.D., director of CDER’s Office of edical Policy; and Lawrence Lesko, Ph.D., director of CDER’s Office of Clinical Pharmacology and Biopharmaceutics. Academic and industrial representatives will also contribute to the conference.

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