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 […]

The FDA and CTTI announced 8 newly selected representatives for the PEC with 2-year terms starting in January 2024. They will join the existing 8 members. […]

On March 27, 2020, “the Coronavirus Aid, Relief, and Economic Security Act” (or the “CARES Act”) (Public Law No. 116-136,) was signed into law. The CARES […]

4/4/2023 Gohibic (757KB) (reissued April 12, 2023) Gohibic is authorized for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical […]