General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products

On 7 September 2022 the FDA published draft guidance on clinical pharmacology considerations for pediatric studies.

This guidance assists sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs) under section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), biologics license applications (BLAs) under section 351(a) of the Public Health Service Act (PHS Act), and supplements to such applications who are planning to conduct clinical studies in pediatric populations. In addition, this guidance assists clinical investigators in the design and planning of, and Institutional Review Boards (IRBs) in the assessment of, clinical studies in pediatric populations.

Read more online 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /