Two draft guidances have been published for comment: Pediatric Drug Development Under the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA): Scientific Considerations addressing selected clinical, scientific, and ethical issues regarding the development of drugs for paediatric use
Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act intended to assist in compliance with the paediatric study requirements under PREA, and describing the process for qualifying for paediatric exclusivity and the protections that paediatric exclusivity offers under the BPCA.
The guidance documents revise and replace the previous Guidances for Industry (withdrawn in 2013). Comments can be submitted until 17 July 2023.
FDA implemented the International Council for Harmonisation (ICH) Q9(R1) Quality Risk Management (QRM) guideline, providing principles and examples of tools for QRM, including development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products. This final guidance replaces the draft guidance published in June 2022.
Final Guidance available for Testing High-Risk Drug Components for Diethylene Glycol (DEG) and Ethylene Glycol (EG). This guidance replaces the 2007 version and provides recommendations to manufacturers, re-packagers, other suppliers of high-risk drug components, and compounders to prevent the use of drug components contaminated with DEG and EG, which has led to more than 300 deaths.
FDA releases two Discussion Papers on Artificial Intelligence (AI) and Machine Learning (ML) in Development of Drug & Biological Products and in Manufacturing and seeks feedback on the key areas discussed in the context of drug development, which will complement and inform future guidance on AI/ML in drug development.
The Center for Devices and Radiological Health (CDRH) now enables users to track medical device premarket submissions. The online progress tracker has a dashboard that displays the status of FDA's progress in near real-time.
Also of note: Starting 01 October 2023, all 510(k) submissions (Class I, II, and III devices for which a Premarket Approval application is not required), must be submitted as electronic submissions using eSTAR unless exempted.
Center for Drug Evaluation and Research (CDER) published its first quarterly Regulatory Science Newsletter featuring new developments, opportunities, and initiatives in drug development and regulatory science, with the goal of advancing medical product development.