FDA issues final guidelines on the development of pediatric anti-infectives
Posted on December 13, 2021 | Through
The guide provides recommendations for the development of anti-infective drugs, including antibacterials, antifungals and antiparasitics, for pediatric populations.
A draft guidance was released in June 2020. (RELATED: Development of pediatric anti-infectives addressed by the FDA, Regulatory guidance, June 29, 2020).
The guide notes some of the challenges in pediatric drug development, including developmental changes in newborns and young children that can affect drug absorption and distribution. Additionally, the ability to collect test samples from sources such as blood and cerebrospinal fluid from this population is limited.
The guide discusses methods for extrapolating efficacy data from studies in adults, how to collect and analyze safety data and criteria for performing juvenile toxicology studies for them. pediatric populations.
The agency also encourages sponsors to meet with them early on to discuss initial pediatric study plans (iPSPs), usually no later than 60 days after the end of phase 2 meetings.
The guide also refers sponsors to the International Council for Harmonization (ICH) guidelines covering non-clinical safety testing to support the development of pediatric pharmaceuticals, including the S11 guideline on Nonclinical Safety Testing to Support Pediatric Pharmaceutical Development, the M3 (R2) directive Non-clinical safety studies for the conduct of clinical trials in humans and marketing authorizations for pharmaceutical productsand FDA guidelines Nonclinical Safety Assessment of Pediatric Drugs.
For cell and gene therapy products, the agency recommends that sponsors consult its guide entitled Preclinical evaluation of experimental cell and gene therapy products.
More development considerations
The guide provides additional considerations for the safety data needed to support the development of anti-infectives for this population.
Developers can use safety data from non-clinical studies and the adult population to help identify adverse events of interest in pediatric patients. probably with decreasing age. These situations may merit additional safety assessments.
The finalized version also offers more examples of when the FDA may recommend juvenile toxicology studies, for example when “there is insufficient data from previous clinical experience, or when safety concerns cannot be adequately addressed. in other non-clinical studies âand that the medicinal product is primarily intended for use in pediatrics. population.
FDA incorporates comments
The FDA incorporated a comment from the Biotechnology Industry Organization (BIO) to clarify that the scope of the guidelines should include antibacterials, antifungals, and antivirals. The original guidelines did not include this clarification.
The Global Partnership for Antibiotic Research and Development (GARDP) had asked the FDA to include more information on how to approach the use of anti-infective drugs in newborns, because these drugs constitute “an important class of drugs in this population”.
The guidelines, in wording taken from the project, indicate that more detailed information on clinical pharmacology considerations for neonates, such as sample size, pharmacokinetic sampling, and data analysis, can be found in several other FDA guidelines, including General Clinical Pharmacology Considerations for Neonatal Drug and Biologic Studies and his General considerations for pediatric studies of drugs and biologicals.
Â© 2021 Society of Regulatory Affairs Professionals.