FDA approves Xtoro to treat swimmer’s ear
The U.S. Food and Drug Administration today approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear.
Archive for the ‘Drug Safety Information Podcasts’ category
FDA approves first pathogen reduction system to treat plasma
The U.S. Food and Drug Administration today approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI).
FDA announces Pharmacy Compounding Advisory Committee members
The U.S. Food and Drug Administration today announced the membership of the Pharmacy Compounding Advisory Committee. The committee is comprised of 14 members – 12 voting and two non-voting – who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic […]
FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency
Today, the U.S. Food and Drug Administration (FDA) allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns.
FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency
Today, the U.S. Food and Drug Administration (FDA) allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns.
FDA clears test that helps predict the risk of coronary heart disease
The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks.
FDA clears test that helps predict the risk of coronary heart disease
The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks.
FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis
The U.S. Food and Drug Administration today announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of healthcare settings.
FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis
The U.S. Food and Drug Administration today announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of healthcare settings.
FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer
The U.S. Food and Drug Administration today expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).
RZM Food Factory to cease operations for repeated food safety violations
William H. Oshiro, owner of RZM Food Factory, has agreed to stop processing and distributing food until he demonstrates to the FDA that RZM Food Factory’s facility and practices comply with federal food safety requirements. The agreement, known as a consent decree of permanent injunction, was signed by a federal judge and entered in the […]
FDA approves first test to confirm the presence of Human T-cell Lymphotropic Virus-I/II antibodies
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). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test. […]
FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV
The U.S. Food and Drug Administration today approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90 percent of […]
OtisMed Corporation, former CEO plead guilty for distributing FDA-rejected cutting guides for knee replacement surgeries
OtisMed Corporation (OtisMed) and its former chief executive officer, Charlie Chi, admitted today to intentionally distributing knee replacement surgery cutting guides after their application for marketing clearance had been rejected by the U.S. Food and Drug Administration.
FDA resolves criminal and civil actions against Main Street Family Pharmacy
Main Street Family Pharmacy, LLC, a compounding pharmacy in Newbern, Tennessee, and the company’s co-owner, David A. Newbaker, each pleaded guilty today in the United States District Court for the Western District of Tennessee to one misdemeanor criminal violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA approves Jakafi to treat patients with a chronic type of bone marrow disease
The U.S. Food and Drug Administration today approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition.
California seafood company to halt production until FDA documents correction of unsanitary practices
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.
FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia
The U.S. Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.
FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia
The U.S. Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.