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Agency Rule List Outlines 81 Items Related to the FDA

The list, published by the Office of Management and Budget, outlines a host of proposed and/or final rules the FDA “hopes” to publish, or at least consider, in 2019.  Given the state of and the bent towards new or additional regulations in the current administration, this seems like an ambitious agenda for the Agency.

The full list can be found here (the FDA is included in the full Health and Human Services list).  While it would not be practical to list all of the proposed or final rules anticipated, here are a select few that may be of general interest.

  • Investigational New Drug Applications Requirements for Conventional Foods, Dietary Supplements, and Cosmetics (here). Designed to clarify and broaden the criteria for exemption when an IND may be needed for studies evaluating drug uses of products that are lawfully marketed as conventional foods, dietary supplements, or cosmetics and that may be subject to IND submission/review.
  • Post Approval Changes to Approved Applications (here). The proposed rule would update post‑approval changes made to ANDAs, NDA and biologic applications, and certain post-approval reporting requirements.
  • Medication Guides; Patient Medication Information (here). This proposed rule would outline and standardize the medical information that must be dispensed on an outpatient basis.  The FDA will propose to call this new form of information “Patient Medication Information.”  The rule would amend the FDA’s medication guide regulations to add this new format and describe how the FDA will approve this information, how it is to be consistent among platforms, and how the information may be disseminated.
  • Investigational New Drug Application Annual Reporting (here). This proposed rule will amend the annual reporting requirements for INDs.  The new report will be termed a Development Safety Update Report (DSUR).  While being consistent with the current annual reporting requirements, it will incorporate international recommendations and will likely be a less burdensome format for sponsors.

These examples provide just a taste of what may be in store for the drug, device, and biologics industry as we move through 2019 and beyond.  I suggest you may want to take some time and scroll through the entire list to see what might hit the bullseye in your company, or just to be prepared for some of the potential changes and ready to comment on any of the proposed rules.