Day: December 12, 2024

The U.S. Food and Drug Administration (FDA) recently updated its guidance titled “Registration and Listing of Cosmetic Product Facilities and Products.” This document aims to help cosmetic businesses understand the requirements for registering their facilities and listing their products with the FDA. The updated guidance includes finalized frequently asked questions (FAQ) in Appendix B, specifically … Read more

FDA’s Accelerated Approval (AA) pathway has often been a subject of public criticism due to the apparent approval of inefficient drugs based on preliminary and/or partial efficacy data. However, the AA is a conditional approval that can be withdrawn if the conditions are not met. This week, the FDA released a new guidance document whose … Read more