Archives for 2014
Warning Letter for Wellmill LLC/DBA Vitamix Laboratories
FDA Approves Combo Hepatitis C Treatment
The U.S. Food and Drug Administration on Friday approved a new combination treatment for people with chronic hepatitis C virus infection, which can lead to advanced liver disease without treatment.
The drug, Viekira Pak, includes a pill containing three antiviral drugs (ombitasvir, paritaprevir and ritonavir) along with a dasabuvir pill. All but ritonavir are new.
Ebola Response Reveals Double Standard In U.S. Health Care
Since Ebola was first discovered in 1976, there have been an estimated 16 to 22 recorded outbreaks. In August, the World Health Organization designated the most recent outbreak a global emergency.
FDA Warns Antipsychotic Drug May Cause Fatal Skin Reaction
The U.S. Food and Drug Administration issues a warning on Thursday that an antipsychotic drug manufactured by Pfizer could cause a potentially serious and life-threatening skin reaction.
Family of powdered caffeine-overdose victim meets with FDA and lawmakers in quest for regulation
WASHINGTON, D.C. – Sen. Sherrod Brown will meet today with families of two young men who died after overdosing on powdered caffeine, then will present a petition from the families and others to the federal government asking for the bulk powdered stimulant to be banned for retail sale.
ELECTRIC IMPLANTS KILL OFF INFECTIONS, THEN DISSOLVE
Someday, in the not-too-distant future, bacterial infections could be treated by implanting electronics into your body. A team from Tufts University and the University of Illinois at Champaign-Urbana developed a tiny implant that can be inserted into an area of infection (or potential infection) and activated remotely, delivering either heat or drugs to infected tissues, and then dissolving harmlessly.
Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug Substances
These controls were developed through interpretation of regulatory requirements for both nonsterile and sterile biologics manufacturing decades ago and have been replicated based on successful regulatory precedent. The most common approach taken by the biopharmaceutical industry was to establish a secondary layer of environmental control via the application of area or room air classification. This was in addition to the primary approach of designing and operating contained processes with qualified cleaning, and using sterilization procedures with appropriate microbial and viral controls.
Happy Thanksgiving Everyone!
FDA warns against using laparoscopic power morcellators to treat uterine fibroids
Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.
Warning Letter for Wells Pharmacy Network
Benjamin H. David, President
CEO
Wells Pharmacy Network, LLC
3420 Fairlane Farms Road, Suite 300
Wellington, FL 33414