Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs At the FDA, we’ve been working for years to anticipate and prepare for the challenges […]

For Immediate Release: March 14, 2024 Today, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

FDA has released several FRNs over the past few years covering the PQ/CMC project. As new sections of Module 3 eCTD (Electronic Common Technical Document) are […]

UPDATE (Jan. 8, 2024): FDA is aware that some providers, including hospital or health-system pharmacies, may be preparing other STS products for patient use in place of […]

“Q&A with FDA” provides engaging conversation and discussion about the latest regulatory topics. In this podcast series, FDA’s Division of Drug Information will answer some of […]

FDA’s Patient Affairs is responsible for managing the Agency’s Patient Listening Session program. This page contains a list of all the Patient Listening Sessions that have been […]

  RLD Name and NDA Number ANDA Number ANDA Applicant Active Ingredient Name, Dosage Form, Strength  Date of Approval Eligible for CGT Exclusivity CGT Exclusivity Forfeiture […]

[3-13-2024] FDA reminds consumers not to purchase or use Govvi WOW!. FDA laboratory analysis confirmed an additional sample of Govvi WOW! contained undeclared DMHA, in addition […]