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FDA’s latest regulatory agenda adds proposed rules for pediatric study plans, GMPs and DSCSA (Catapult’s regulatory round-up – 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 FDA plans to propose or finalize in the near future. The agenda includes:

  • 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.
  • 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.
  • proposed rule, set to be published in February 2025 which 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”.
  • plans to publish its 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)

Published on the 30th of August 2024 in Catapult’s regulatory round-up for August 2024.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA’s latest regulatory agenda adds proposed rules for pediatric study plans, GMPs and DSCSA (Catapult’s regulatory round-up – August 2024). ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/12mjt


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