Home Tags Food & Drug Administration

Tag: Food & Drug Administration

The U.S. Food and Drug Administration is requiring labeling changes to nonsteroidal anti-inflammatory drugs that warn of the risks of taking these drugs at 20 weeks of pregnancy or later

FDA Requiring Labeling Changes to NSAIDs Warning of Risks in Pregnancy

Labeling must indicate risks to unborn baby with NSAID use at 20 weeks of pregnancy or later
Warning letters have been sent to five companies for illegally selling dietary supplements that contain cesium chloride

FDA Warns Companies About Illegal Sales of Dietary Supplements

The supplements contain cesium chloride, but no cesium chloride-containing products are FDA-approved
Regeneron Pharmaceuticals Inc. said Wednesday that it is seeking emergency approval from the U.S. Food and Drug Administration for an experimental antibody cocktail given to President Donald Trump shortly after he was diagnosed with COVID-19.

Maker of Antibody Cocktail Trump Took Seeks Emergency Use Authorization

Although effectiveness has not yet been seen in humans, drug has shown promise in treating mild cases of COVID-19
Following weeks of delay

White House Approves Tougher Rules for COVID-19 Vaccine Development

Guidelines recommend participants in late-stage trials be followed for a median of at least two months
Eli Lilly and Co. is seeking U.S. approval for emergency use of an experimental antibody therapy for COVID-19.

Company Seeks FDA Emergency Approval for COVID-19 Antibody Therapy

Request based on partial clinical trial findings suggesting the drug reduces symptoms in mild or moderate COVID-19
New drug applications for prescription opioids for pain have been based on pivotal trials of short or intermediate duration

New FDA Applications for Opioids Often Based on Short Trials

Most products for treating chronic pain approved based on narrowly defined populations of patients
Recalled wood ear mushrooms imported by Wismettac Asian Foods Inc.

Wood Ear Mushrooms Linked to Salmonella Outbreak

Mushrooms were distributed in six packs of 5-lb bags to restaurants in more than 30 states, Canada
In response to reports of misuse and abuse of benzodiazepines

FDA Requiring Labeling Changes to Benzodiazepine Prescribing Information

Update to Boxed Warning must include risks for abuse, misuse, addiction, physical dependence, withdrawal reaction
Stricter guidelines for emergency authorization use of a vaccine against the new coronavirus could soon be issued by the U.S. Food and Drug Administration.

Stricter Vaccine Approval Rules Coming From FDA

If approved by the White House, revised guidelines could be released as early as next week
Perrigo inhalers have been recalled because they could clog and not provide patients with any or enough medication

Perrigo Asthma Inhalers Recalled Due to Clog Risk

Some of the recalled albuterol sulfate inhalers stop working after several uses