Posted by Michael Wonder on 29 Sep 2021
Benefit-risk assessment for new drug and biological products
29 September 2021 - The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain pre-market and post-market regulatory decisions that the FDA makes about new drug applications submitted under section 505(c) of the Federal Food, Drug, and Cosmetic Act as well as biologics license applications submitted under section 351(a) of the Public Health Service Act.
This guidance first articulates important considerations that factor into the Center for Drug Evaluation and Research’s and the Center for Biologics Evaluation and Research’s benefit-risk assessments, including how patient experience data can be used to inform the benefit-risk assessment.
