Advocating for Drug Regulation Reform Facing unintended consequences from FDA policies on unapproved drugs that could have removed common medical gases from the market, the Compressed Gas Association (CGA) turned to Holland & Knight's Public Policy & Regulation Practice Group to achieve a legislative solution. The historic reforms that resulted helped to avoid a potentially catastrophic result for the industry. The use of medical gases pre-dates the new drug application (NDA) provisions in the Federal Food, Drug, and Cosmetic Act. Consequently, most medical gases were sold without NDA approval. As a result of the Unapproved Drugs Initiative — which the Food and Drug Administration (FDA) launched in 2006 to remove all unapproved drugs from the marketplace —medical gases such as oxygen, nitr

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