FDA’s latest regulatory agenda adds proposed rules for pediatric study plans, container closure GMPs
Regulatory News | 15 August 2024 |
The US Department of Health and Human Services (HHS) recently published its semiannual regulatory agenda for Spring 2024 that includes 12 proposed and 10 final rules the Food and Drug Administration (FDA) plans to propose or finalize in the near future.
“The regulatory actions forecasted in this Agenda reflect the priorities of HHS Secretary Xavier Becerra and the Biden-Harris Administration,” HHS wrote in its preamble. “Accordingly, this Agenda contains rulemakings aimed at ensuring that the nation is well-prepared to manage the long-term effects of COVID-19 going forward, building and expanding access to affordable, quality health care, addressing health disparities and promoting equity, lowering prescription drug costs, and boosting the mental health and well-being of children and families, among other policy priorities.”
While some of the rules featured in the regulatory agenda are new for this edition, several of the proposed and final rules that make an appearance have been listed in previous agendas and the agency does not always adhere to the timeframes for issuing rules laid out in the agenda.
Included in the agenda are FDA’s plans to propose new regulations covering the submission of initial pediatric study plans (iPSPs) by October 2024. This would implement provisions under the Federal Food, Drug, and Cosmetic Act (FD&C Act) which incorporate the Pediatric Research Equity Act (PREA) relating to pediatric study plans giving FDA the authority to require pediatric studies for certain drugs and biological products.
In July 2020, FDA published a final guidance detailing the information that should be included in the iPSPs. (RELATED: FDA provides guidance on preparation and submission of pediatric study plans, Regulatory Focus 5 August 2020).
FDA said “this proposed rule, if finalized, would implement the pediatric study plans provisions of the FD&C Act, and exercise the authority granted to the Secretary in the provisions of the FD&C Act governing exemptions from pediatric study requirements.”
FDA also announced plans to propose a new rulemaking that would establish a new 21 CFR 321 to clarify FDA's expectations for sponsors conducting clinical pharmacology, and clinical and analytical bioavailability (BA) and bioequivalence (BE) studies supporting marketing applications for drugs and biological products.
“The proposed rule would specify needed basic study conduct requirements to enable FDA to ensure those studies are conducted appropriately and to verify the reliability of study data from those studies,” said the agency. “This regulation would align with FDA's other good practice regulations, would also be consistent with current industry best practices, and would harmonize the regulations more closely with related international regulatory expectations.” FDA plans to publish a proposed rulemaking in October 2024.
Another proposed rule set to be published in February 2025 would amend current Good Manufacturing Practice (GMPs) for drugs to “clarify and modernize the regulations by adding requirements for quality management systems and controls over components and drug product containers and closures.”
FDA also announced plans to publish its widely anticipated final rule establishing uniform licensing standards for wholesale distributors and third-party-logistics providers (3PLs) mandated under the 2013 Drug Supply Chain Security Act (DSCSA). The law mandated that these rules be in place before these trading partners take possession of prescription drug products. Plans are in the works to publish a final rule in May 2026.
The proposed rule on wholesale distributor and 3PL licensing standards was published in February 2022. FDA said it would issue an amendment to remove certain defunct rules related to prescription drug marketing that DSCSA has made obsolete. (RELATED: FDA issues long-awaited licensing rules for drug distributors and 3PLs, Regulatory Focus 3 February 2022).
Agenda
“The regulatory actions forecasted in this Agenda reflect the priorities of HHS Secretary Xavier Becerra and the Biden-Harris Administration,” HHS wrote in its preamble. “Accordingly, this Agenda contains rulemakings aimed at ensuring that the nation is well-prepared to manage the long-term effects of COVID-19 going forward, building and expanding access to affordable, quality health care, addressing health disparities and promoting equity, lowering prescription drug costs, and boosting the mental health and well-being of children and families, among other policy priorities.”
While some of the rules featured in the regulatory agenda are new for this edition, several of the proposed and final rules that make an appearance have been listed in previous agendas and the agency does not always adhere to the timeframes for issuing rules laid out in the agenda.
Included in the agenda are FDA’s plans to propose new regulations covering the submission of initial pediatric study plans (iPSPs) by October 2024. This would implement provisions under the Federal Food, Drug, and Cosmetic Act (FD&C Act) which incorporate the Pediatric Research Equity Act (PREA) relating to pediatric study plans giving FDA the authority to require pediatric studies for certain drugs and biological products.
In July 2020, FDA published a final guidance detailing the information that should be included in the iPSPs. (RELATED: FDA provides guidance on preparation and submission of pediatric study plans, Regulatory Focus 5 August 2020).
FDA said “this proposed rule, if finalized, would implement the pediatric study plans provisions of the FD&C Act, and exercise the authority granted to the Secretary in the provisions of the FD&C Act governing exemptions from pediatric study requirements.”
FDA also announced plans to propose a new rulemaking that would establish a new 21 CFR 321 to clarify FDA's expectations for sponsors conducting clinical pharmacology, and clinical and analytical bioavailability (BA) and bioequivalence (BE) studies supporting marketing applications for drugs and biological products.
“The proposed rule would specify needed basic study conduct requirements to enable FDA to ensure those studies are conducted appropriately and to verify the reliability of study data from those studies,” said the agency. “This regulation would align with FDA's other good practice regulations, would also be consistent with current industry best practices, and would harmonize the regulations more closely with related international regulatory expectations.” FDA plans to publish a proposed rulemaking in October 2024.
Another proposed rule set to be published in February 2025 would amend current Good Manufacturing Practice (GMPs) for drugs to “clarify and modernize the regulations by adding requirements for quality management systems and controls over components and drug product containers and closures.”
FDA also announced plans to publish its widely anticipated final rule establishing uniform licensing standards for wholesale distributors and third-party-logistics providers (3PLs) mandated under the 2013 Drug Supply Chain Security Act (DSCSA). The law mandated that these rules be in place before these trading partners take possession of prescription drug products. Plans are in the works to publish a final rule in May 2026.
The proposed rule on wholesale distributor and 3PL licensing standards was published in February 2022. FDA said it would issue an amendment to remove certain defunct rules related to prescription drug marketing that DSCSA has made obsolete. (RELATED: FDA issues long-awaited licensing rules for drug distributors and 3PLs, Regulatory Focus 3 February 2022).
Agenda
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