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Company Info

U.S. Food & Drug Administration

U.S. Food & Drug Administration

Academia / Non-Profit

Overview

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
U.S. Food & Drug Administration
Contributions
148 Contributions1 / 8
U.S. Food & Drug Administration
Gene Therapy

FDA Approves First Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency

U.S. Food & Drug Administration

PR-11-24-NI-100Nov 15, 2024
U.S. Food & Drug Administration
FDA

U.S. Food and Drug Administration

U.S. Food & Drug Administration

PR-10-24-NI-44Oct 14, 2024
U.S. Food & Drug Administration
CDMO

FDA Approves First Treatment for Niemann-Pick Disease, Type C

U.S. Food & Drug Administration

PR-09-24-NI-12Sep 23, 2024
U.S. Food & Drug Administration
Alzheimer's Diagnostic Test

FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer's Disease

U.S. Food & Drug Administration

PR-M05-22-02May 04, 2022
U.S. Food & Drug Administration
COVID-19 Breathalyzer Diagnostic

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

U.S. Food & Drug Administration

PR-M04-22-09Apr 14, 2022
U.S. Food & Drug Administration
Regulatory

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

U.S. Food & Drug Administration

PR-M03-22-03Mar 07, 2022
U.S. Food & Drug Administration

FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer

U.S. Food & Drug Administration

PR-M11-20-028Dec 02, 2020
U.S. Food & Drug Administration
FDA Approval

FDA Approves First Treatment for Ebola Virus

U.S. Food & Drug Administration

PR-M10-20-10Oct 15, 2020
U.S. Food & Drug Administration
FDA Approval

FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients

U.S. Food & Drug Administration

PR-M09-20-NI-04Sep 02, 2020
U.S. Food & Drug Administration
Diagnostic Testing

FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect COVID-19 Test

U.S. Food & Drug Administration

PR-M08-20-NI-27Aug 17, 2020
U.S. Food & Drug Administration
Liquid Biopsy

FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

U.S. Food & Drug Administration

PR-M08-20-NI-17Aug 10, 2020
U.S. Food & Drug Administration
COVID-19 Testing

FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing

U.S. Food & Drug Administration

PR-M07-20-NI-29Jul 21, 2020
U.S. Food & Drug Administration
FDA

FDA Prepares for Resumption of Domestic Inspections with New Risk Assessment System

U.S. Food & Drug Administration

PR-M07-20-NI-016Jul 13, 2020
U.S. Food & Drug Administration
FDA

FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines

U.S. Food & Drug Administration

PR-M06-20-NI-041Jul 02, 2020
U.S. Food & Drug Administration
COVID-19 Testing

The FDA Confirms Certain COVID-19 Serology and Antibody Tests Should Not Be Used

U.S. Food & Drug Administration

PR-M06-20-NI-035Jun 26, 2020
U.S. Food & Drug Administration
Clinical Trials

FDA Announces First of Its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials

U.S. Food & Drug Administration

PR-M06-20-NI-032Jun 25, 2020
U.S. Food & Drug Administration
FDA Approval

FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD

U.S. Food & Drug Administration

PR-M06-20-NI-021Jun 16, 2020
U.S. Food & Drug Administration
FDA Alert

FDA Alerts Patients of Amneal and Impax Laboratories Epinephrine Auto-Injector Device Malfunctions

U.S. Food & Drug Administration

PR-M06-20-NI-015Jun 11, 2020
U.S. Food & Drug Administration
FDA

FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse

U.S. Food & Drug Administration

PR-M06-20-NI-011-1519Jun 08, 2020
U.S. Food & Drug Administration
FDA Antibody Tests

FDA Provides Promised Transparency for Antibody Tests

U.S. Food & Drug Administration

PA1538May 26, 2020
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