Unified Agenda: A look at FDA’s upcoming rulemaking

Regulatory NewsRegulatory News | 17 June 2021 |  By 

Under the Biden administration’s first regulatory agenda, the US Food and Drug Administration (FDA) is preparing to promulgate three dozen proposed and final rules related to human drugs, biologics, medical devices and clinical trials.
The proposed and final rules are detailed in the belated Spring 2021 unified agenda released by the Office of Management and Budget last week. Many of the rules are holdovers from previous biannual agendas, such as a final rule on the de novo classification process for medical devices and a proposed rule on modernizing the quality system regulation to harmonize with the international standard, ISO 13485:2016. Both rules, as well as proposed rules related to the classification of over-the-counter hearing aids and the classification of spinal spheres for use in intervertebral fusion procedures, are slated for publication this month, according to the latest agenda.
Other final rules slated for a notice of proposed rulemaking (NPRM) in the coming months include rules on “intended uses” and summary reporting under the Right to Try Act, as well as a rule that would allow the use of drug master files (DMFs) for so-called “deemed to be a license” biologics. (RELATED: FDA issues proposed rule clarifying stance on intended use, Regulatory Focus 23 September 2020; : FDA proposes reporting rule for Right to Try Act, Regulatory Focus 23 July 2020; FDA proposes new rule on allowing the Use of DMFs for Transitioning Biologics, Regulatory Focus 27 June 2019)
However, the agency’s deadline for one item that appears on the agenda, a final rule that would end FDA’s quarterly reporting of certain device decisions, has already come and gone. (RELATED: FDA wants to end quarterly reporting of device decisions, Regulatory Focus 16 December 2019)
“This Agenda presents the regulatory activities that the Department expects to undertake in the foreseeable future to advance this mission,” the Department of Health and Human Services wrote in its preamble to the agenda. “The regulatory actions forecasted in this Agenda reflect the priorities of the Biden-Harris Administration and HHS Secretary Xavier Becerra. Accordingly, this Agenda contains rulemakings aimed at advancing equity and ensuring nondiscrimination in health; ending the COVID-19 public health emergency; enhancing access to quality, affordable health care; addressing child welfare and maternal health; safeguarding the quality of medical products; protecting the public health by reducing tobacco use; revising prior actions that are inconsistent with the policy of this Administration; and supporting other priority areas.”
HHS also clarifies that the previous unified agenda and accompanying Statement of Regulatory Priorities issued in Fall 2020 by the Trump administration “no longer reflect views of the Department or this Administration.”
Agency Rule List (FDA)
Proposed rules
Investigational New Drug Applications; Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement, or Cosmetic December 2021
National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers September 2021
Post Approval Changes to Approved Applications April 2022
Certain Requirements Regarding Prescription Drug Marketing (203 Amendment) September 2021
Current Good Manufacturing Practice for Positron Emission Tomography Drugs December 2021
Nonprescription Drug Product With an Additional Condition for Nonprescription Use November 2021
Medication Guide; Patient Medication Information October 2021
Updated Regulations for Medical Gases August 2021
Harmonizing and Modernizing Regulation of Medical Device Quality Systems June 2021
Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards December 2021
Institutional Review Boards; Cooperative Research December 2021
Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen or Antibody Tests September 2021
Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations June 2021
Classification of Wound Dressings Containing Antimicrobials and/or Other Chemicals December 2021
Amendments to Patent Term Restoration August 2021
Amendment to Records and Reports Concerning Adverse Drug Experiences on Marketed Prescription Drugs for Human Use Without Approved New Drug Applications August 2021
Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food Drug and Cosmetic Act December 2021
Classification of Spinal Spheres For Use in Intervertebral Fusion Procedures June 2021
Medical Devices; Cardiovascular Devices; Classification of More Than Minimally Manipulated Allograft Heart Valves December 2021
Investigational New Drug Application Annual Reporting October 2021
Amending Regulations That Require Multiple Copies Submissions December 2021
Revising the National Drug Code Format and Drug Labeling Barcode Requirements September 2021
Conduct of Analytical and Clinical Pharmacology, Bioavailability and Bioequivalence Studies March 2022
Administrative Destruction of Certain Devices Refused Admission to the United States August 2021
Final rules
Mammography Quality Standards Act September 2021
Biologics License Applications and Master Files July 2021
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations February 2022
Medical Device De Novo Classification Process June 2021
Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products September 2021
Updating Public Information Regulations August 2021
Revision of Product Jurisdiction Regulations February 2022
Amendments to the List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act December 2021
Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications May 2021
Annual Summary Reporting Requirements Under the Right to Try Act December 2021
Revocation for the Regulation for Human Tissue Intended For Transplantation and Human Dura Mater December 2021
Regulations Regarding "Intended Uses" July 2021


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