Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation (Final Rule)

FDA is issuing this final rule repealing a regulation that requires an FDA-approved new drug application (NDA) or abbreviated new drug application (ANDA) for any drug product that is sterilized by irradiation. Repealing the regulation will mean that over-the-counter (OTC) drug products that are generally recognized as safe and effective, are not misbranded, and comply with all applicable regulatory requirements can be marketed legally without an NDA or ANDA, even if they are sterilized by irradiation. FDA is taking this action because the irradiation regulation is out of date and unnecessary.

We estimate the final rule to have insignificant costs for reading and understanding the rule as it would only affect one firm every ten years. The final rule would produce benefits from avoiding both industry costs to prepare one NDA or ANADA every 10 years, and government costs to review one NDA or ANADA every 10 years. We estimate the annualized benefits across both industry and government at about $0.06 million at a 7 percent discount rate and $0.05 million at a 3 percent discount rate, over 10 years.

Regulatory Impact Analysis

Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation (Final Rule) (PDF - 173kb)

Federal Register: 84 FR 68331, December 16, 2019

Docket: FDA-2017-N-6924