How S 1049 changes current law

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill adds requirements for communication plans in risk evaluation and mitigation strategies for certain drugs under the Federal Food, Drug, and Cosmetic Act.

• 21 U.S.C. 355-1(e)(3)

  (D) disseminating information to health care providers about the meaning of terms related to drug formulations or properties that are described in the drug labeling, including information about the limitations or patient care implications of such formulations or properties, and how such formulations or properties may be related to serious adverse drug events associated with use of the drug.

  This change requires the dissemination of specific information related to drug formulations and properties to healthcare providers.