Tag: Food & Drug Administration
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
FDA Warns Companies About Illegal Sales of Dietary Supplements
The supplements contain cesium chloride, but no cesium chloride-containing products are FDA-approved
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
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
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 FDA Applications for Opioids Often Based on Short Trials
Most products for treating chronic pain approved based on narrowly defined populations of patients
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
FDA Requiring Labeling Changes to Benzodiazepine Prescribing Information
Update to Boxed Warning must include risks for abuse, misuse, addiction, physical dependence, withdrawal reaction
Stricter Vaccine Approval Rules Coming From FDA
If approved by the White House, revised guidelines could be released as early as next week
Perrigo Asthma Inhalers Recalled Due to Clog Risk
Some of the recalled albuterol sulfate inhalers stop working after several uses
