FDA

FDA Clears New Indications for Existing Lyme Disease Tests That May Help Streamline Diagnoses

July 31, 2019

Today, the Food and Drug Administration (FDA) announces it has cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current two-step process in which a separate protein test called a Western Blot must be run after the initial EIA test.

FDA Authorizes Marketing of First Diagnostic Test for Detecting Zika Virus Antibodies

May 29, 2019

The Food and Drug Administration (FDA) announces it has authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood.

FDA Permits Marketing of First Diagnostic Test to Aid in Detecting Prosthetic Joint Infections

May 24, 2019

The Food and Drug Administration (FDA) has permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being evaluated for revision surgery, which is

FDA Clears First Diagnostic Tests for Extragenital Testing for Chlamydia and Gonorrhea

May 23, 2019

The Food and Drug Administration (FDA) announces it has cleared for marketing two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually-transmitted infections, respectively, chlamydia and gonorrhea, through diagnostic testing

FDA Approves First Vaccine for the Prevention of Dengue Disease in Endemic Regions

May 7, 2019

The Food and Drug Administration (FDA) announces the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in ende

FDA Issues Statement on Agency's Continued Confidence in Safety of MMR Vaccine

April 24, 2019

Peter Marks, MD, PhD, director of the Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research, has issued the following statement on the agency's continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine:

FDA Issues Final Rule on Safety and Effectiveness of Consumer Hand Sanitizers

April 13, 2019

The Food and Drug Administration (FDA) today issued a final rule designed to help ensure that hand sanitizers a

FDA Approves First Two-Drug Regimen for HIV-Infected Patients Who Have Never Received Antiretroviral Treatment

April 9, 2019

The Food and Drug Administration (FDA) today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated w

FDA Issues Statement on Shutdown of Large Contract Sterilization Facility

March 27, 2019

Food and Drug Administration (FDA) commissioner Scott Gottlieb, MD, has issued the following statement on steps the agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility:

FDA Addresses Efforts to Promote Blood Product Pathogen-Reduction Technologies

March 27, 2019

FDA commissioner Scott Gottlieb, MD, and director of FDA’s Center for Biologics Evaluation and Research Peter Marks, MD, PhD, have issued the following statement on efforts to promote and foster blood pathogen reduction technologies:

FDA

Pages