Regulatory Science Update: FDA and International Serious Adverse Events Consortium Complete Third Data Release

Jim Vititoe | March 17, 2010

FDA NEWS RELEASE
For Immediate Release:
Media Inquiries: FDA Press Office, 301-796-4540
Data focus on genetic basis of drug-induced liver injury and serious skin reaction
The U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC) today announced the third release of data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions [...]

SPRINGFIELD BUSINESS OWNER PLEADS GUILTY TO FRAUDULENTLY MARKETING DIETARY SUPPLEMENTS

Jim Vititoe | March 17, 2010

FOR IMMEDIATE RELEASE
INTERNET BUSINESSES GENERATED NEARLY $12 MILLION WITH FALSE CLAIMS TO PREVENT, CURE DISEASES
SPRINGFIELD, Mo. – Beth Phillips, United States Attorney for the Western District of Missouri, announced today that a Springfield, Mo., business owner has pleaded guilty in federal court to [...]

U.S. Department of Transportation Responds to Third Toyota Recall

Jim Vititoe | February 17, 2010

WASHINGTON, D.C. — The U.S. Department of Transportation learned today of a third Toyota recall involving 2010 Prius hybrids and Lexus HS 250h vehicles experiencing brake system problems. Some 2010 Camrys prone to brake fluid leaks have also been recalled.
“Last Thursday, NHTSA opened a formal investigation of 2010 Toyota Prius hybrid vehicles in response [...]

CPSC Warns of In-Home Drowning Dangers with Bathtubs, Bath Seats, Buckets

Jim Vititoe | October 7, 2009

NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs
Washington, DC 20207
FOR IMMEDIATE RELEASE
October 7, 2009
Release #10-008
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
CPSC Warns of In-Home Drowning Dangers with Bathtubs, Bath Seats, Buckets
WASHINGTON, D.C. - The end of outdoor swimming and pool season doesn’t mean the end of [...]

FDA Moves Forward on Implementation of Tobacco Law

Jim Vititoe | August 25, 2009

FDA NEWS RELEASE
For Immediate Release: Aug. 25, 2009
Media Inquiries: Kathleen K. Quinn, 301-796-4617, Kathleen.Quinn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Moves Forward on Implementation of Tobacco Law
The U.S. Food and Drug Administration today announced an action regarding the implementation of the Family Smoking Prevention and Tobacco Control Act. The Agency has officially established the Tobacco Products Scientific Advisory Committee [...]

Sabril Approved by FDA to Treat Spasms in Infants and Epileptic Seizures

Jim Vititoe | August 21, 2009

FDA NEWS RELEASE
For Immediate Release: Aug. 21, 2009
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to 2 years. Sabril is the first drug in the United States approved to treat the disorder, characterized [...]

FDA Proposes Mandatory Electronic Safety Reporting

Jim Vititoe | August 20, 2009

FDA NEWS RELEASE
For Immediate Release: Aug. 20, 2009
Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov; Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Proposes Mandatory Electronic Safety Reporting
New Rules will Help Strengthen Postmarket Safety Data Collection
The U.S. Food and Drug Administration is proposing to amend postmarket safety reporting regulations for three of its centers to require that manufacturers and [...]

Accelerated Approval of Hiberix to Help Sustain Adequate Vaccine Supply Vaccine Approved as a Hib Booster Dose

Jim Vititoe | August 20, 2009

For Immediate Release: Aug. 19, 2009
Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Accelerated Approval of Hiberix to Help Sustain Adequate Vaccine Supply
Vaccine Approved as a Hib Booster Dose
The U.S. Food and Drug Administration today approved Hiberix, a Haemophilus influenzae Type b (Hib) vaccine, as a booster dose for children 15 months through 4 years old. [...]

FDA Launches New Center for Tobacco Products Noted Public Health, Veteran’s Care Expert Will Lead Agency’s Effort to Regulate Tobacco

Jim Vititoe | August 20, 2009

FDA NEWS RELEASE
For Immediate Release: August 19, 2009
Media Inquiries: Raymond Formanek Jr., 301-796-4677; raymond.formanek@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Launches New Center for Tobacco Products
Noted Public Health, Veteran’s Care Expert Will Lead Agency’s Effort to Regulate Tobacco
The U.S. Food and Drug Administration today launched its new Center for Tobacco Products in an historic effort to curb the hundreds [...]

U.S. ATTORNEY NEWS RELEASE: LOCAL PHARMACIST SENTENCED TO 1 YEAR AND 3 MONTHS FOR HEALTHCARE FRAUD AND CAMPAIGN CONTRIBUTION FRAUD; ALSO ENTERS INTO $300,000 CIVIL SETTLEMENT AGREEMENT FOR HEALTHCARE FRAUD

Jim Vititoe | August 17, 2009

Department of Justice
Acting United States Attorney Candace G. Hill
Western District of Kentucky
______________________________________________________________________________
FOR IMMEDIATE RELEASE CONTACT: DAWN MASDEN
MONDAY, AUGUST 17, 2009 PHONE: (502) 582-5911
WWW.USDOJ.GOV/USAO/KYW FAX: (502) 582-5097
LOCAL PHARMACIST SENTENCED TO 1 YEAR AND 3 MONTHS FOR HEALTHCARE FRAUD AND CAMPAIGN CONTRIBUTION FRAUD; ALSO ENTERS
INTO $300,000 CIVIL SETTLEMENT AGREEMENT FOR HEALTHCARE FRAUD
LOUISVILLE, KY - Brian Ullom, age [...]