FDA Seeks Comments on the Content and Format of Substantial Equivalence Reports

On April 2, 2019, the Food and Drug Administration (FDA) published the proposed rule “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence (SE) Reports.” The proposed rule establishes the requirements for the content and form of SE Reports for tobacco products. Additionally, the proposed rule establishes the general procedures FDA will follow to evaluate SE Reports, including procedures for communicating with applicants and for the confidentiality of data in an SE Report. Written comments on information collection issues under the Paperwork Reduction Act are due by May 2, 2019. Written comments on the proposed rule are due by June 17, 2019.

  • Review the rule or submit comments here.
  • Advocacy contact: Charles Jeane at (202) 205-7168.

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