AMDL retains regulatory affairs firm to assist in DR-70 market clearance

By E. Janene Geiss

Philadelphia, Sept. 13 - AMDL, Inc. said Wednesday that it has retained the statistical and regulatory consulting firm R. P. Chiacchierini & Associates of Rockville, Md., to provide additional statistical analysis for the Food and Drug Administration to support the company's request for clearance to market its DR-70 cancer test kit in the United States.

The consulting firm is experienced in all aspects of statistical consulting and regulatory affairs for device and biologic products, AMDL, a Tustin, Calif., diagnostic company, said in a news release.

The firm, which has assisted more than 700 companies with filings, employs former FDA senior management, policy makers, reviewers and other industry personnel, AMDL officials said.

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