FDA Alerts
FDA Approves First Test for Group of Human Retroviruses
The U.S. Food and Drug Administration today approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II).
FDA: Neptune Manufacturing Must Take Steps to Safely Produce Seafood
On December 1, a federal judge from the U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Neptune Manufacturing, Inc., of Los Angeles, and its owners, Alexander Goldring, Peter Oyrekh and Semyon Krutovsky.
Case of Rare Brain Infection Reported in MS Patient Taking Tecfidera
FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died.
FDA Approves First Combination Pill to Treat Hepatitis C
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
FDA Approves New Rx for Combination with Other HIV Medications
On September 24, 2014, FDA approved Vitekta (elvitegravir) 85 mg and 150 mg tablets.
FDA Approves New Rx for Combination with HIV Medications
On September 24, 2014, FDA approved Tybost (cobicistat) 150 mg tablets. Tybost is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection.
Gold Star Smoked Fish Recalls Cold Smoked Steelhead
Gold Star Smoked Fish Corp., located at 570 Smith Street, Brooklyn, NY 11231, is recalling Cold Smoked Steelhead in Vacuum Pack with blue and gold label due to contamination or possible contamination with Listeria monocytogenes .
FDA Wants Breakthrough Ideas for Finding Foodborne Illness
The U.S. Food and Drug Administration is asking for potential breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce.
FDA Allows Marketing of Blood Test for Five Yeast Pathogens
The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.
FDA Unveils Plans to Prevent Foodborne Illness
Based on extensive outreach and public comment, the U.S. Food and Drug Administration today proposed revisions to four proposed rules designed to help prevent food-borne illness.