A bill to direct the National Institute of Arthritis, Metabolism, and Digestive Diseases to conduct such studies as may be necessary to determine the safety and efficacy under section 505 of the Federal Food, Drug, and Cosmetic Act of dimethyl sulfoxide (DMSO) as a topical analgesic and to provide that, if the drug is so determined to be safe and effective, new drug applications may be approved under such section based on the evidence submitted by the institute.

Summary

Requires the Director of the National Institute of Arthritis, Metabolism, and Digestive Diseases to conduct an investigation of the safety and efficacy of dimethylsulfoxide (DMSO) as a topical analgesic for the relief of pain resulting from osteoarthritis, bursitis, and tendonitis. Directs the Director, upon receipt of favorable results from such investigation, to submit an application to the Secretary of Health and Human Services for a determination of the safety and efficacy of DMSO for use as a new drug under the Federal Food, Drug, and Cosmetic Act. Provides that, if such application is approved, the Secretary shall expedite consideration of other applications for the use of DMSO in interstate commerce.

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• Introduced in House

  summary · EN · 10 November 1981

  Open at official source

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