Department of Health and Human Services December 6, 2022 – Federal Register Recent Federal Regulation Documents

This notice announces the cancellation of the December 7, 2022 virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') that was published in the October 11, 2022 Federal Register. This notice also announces a virtual public meeting of the MEDCAC Committee on Monday, February 13 and Tuesday, February 14, 2023. National Coverage Determinations resulting in coverage with evidence development (CED) can expedite earlier Medicare beneficiary access to innovative technology while ensuring that systematic patient safeguards are in place to reduce the risks inherent to new technologies, or to new applications of older technologies. This meeting will examine the general requirements for clinical studies submitted for CMS coverage requiring CED. The MEDCAC will evaluate the CED criteria to assure that CED studies are evaluated with consistent, feasible, transparent and methodologically rigorous criteria and advise CMS on whether the criteria are appropriate to ensure that CED-approved studies will produce reliable evidence that CMS can rely on to help determine whether a particular item or service is reasonable and necessary. This meeting is open to the public in accordance with the Federal Advisory Committee Act.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials.'' The final guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The guidance revises the draft guidance for industry entitled ``E19 Optimisation of Safety Data Collection'' issued in June 2019. The final guidance provides recommendations regarding appropriate use of a selective approach to safety data collection in some late-stage pre- or post-marketing studies of drugs where the safety profile, with respect to commonly occurring adverse events, is well understood and documented. The final guidance is intended to advance important clinical research questions through the conduct of clinical investigations that collect relevant patient data, which will enable an adequate benefit-risk assessment of the drug for its intended use, while reducing the burden to patients from unnecessary tests that may yield limited additional information.