Home Tags Food & Drug Administration

Tag: Food & Drug Administration

The Tandem Diabetes Care t:Slim X2 insulin pump

FDA Approves First Customizable Insulin Pump

Product works by delivering insulin under the skin at set or variable rates
A number of warning/advisory letters have been issued to 17 companies for selling illegal products that claim to prevent

FDA Warns 17 Companies About Illegal Alzheimer Disease Products

The products are often sold on websites and social media and may be ineffective, unsafe
Cablivi (caplacizumab-yhdp) injection has been approved by the U.S. Food and Drug Administration to treat adults with acquired thrombotic thrombocytopenic purpura.

FDA Approves Cablivi for Rare Blood-Clotting Disorder

Drug approved to treat adults with acquired thrombotic thrombocytopenic purpura
Certain lots of Roche Diagnostics test strips should not be used with CoaguChek test meter devices to check levels of the blood thinner warfarin because patients may get inaccurate results and be at risk for serious injury or death

Expanded Recall of Warfarin Level Monitoring Test Strips

Inaccurate results may put patients at risk for serious injury or death
The first generic form of the Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhaler has been approved by the U.S. Food and Drug Administration.

FDA Approves First Generic Version of Advair for Asthma, COPD

Medication approved to treat children aged 4 or older with asthma, adults with asthma or COPD
The U.S. Food and Drug Administration was given an "F" in a new American Lung Association report card evaluating tobacco prevention programs.

FDA Receives an ‘F’ in Tobacco Prevention Report Card

American Lung Association releases State of Tobacco Control 2019 report
The first generic version of Sabril (vigabatrin) has been approved by the U.S. Food and Drug Administration to prevent complex partial seizures in adults and children aged 10 years and older with epilepsy.

FDA Approves First Generic Version of Epilepsy Drug Sabril

Generic equivalents held to same vigorous manufacturing standards as brand-name drugs
Due to the federal government shutdown

FDA Down to 5 Weeks of Funding to Review New Drug Applications

Agency cannot accept new fees or applications until the shutdown is over
Routine inspections of riskier foods will resume as early as today

FDA to Resume Inspections of Riskier Foods

Agency is bringing back about 150 unpaid employees for the inspections of riskier foods
Food inspections have declined due to the partial shutdown of the U.S. government

U.S. Food Supply May Be at Risk Due to Government Shutdown

Number of routine food inspections performed by the FDA dropped sharply