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 […]

Image On December 23, 2021, President Biden signed into law (Public Law 117-79), the “Accelerating Access to Critical Therapies for ALS Act” (ACT for ALS).  The […]

Docket Number: FDA-2024-D-0803 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research It is important to establish an […]

On This Page Date: May 7 – 8, 2024 Day1: Tue, May 7 9:00 AM – 5:00 PM ET Day2: Wed, May 8 9:00 AM – […]