Tag: Food & Drug Administration
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
John Wagner No Longer Heading FDA Office of External Affairs
Departure comes after mishandling of an announcement about experimental therapy for COVID-19
FDA Could Green-Light COVID-19 Vaccines Before Clinical Trials Completed
Data, not politics, would guide any FDA decision on vaccines, according to agency commissioner
FDA Approves Wider Use of Plasma as COVID-19 Treatment
President Donald Trump announced emergency approval as 'breakthrough' treatment during a news briefing Sunday
White House Blocks FDA’s Power to Regulate Lab Tests
FDA staunchly opposes the change, arguing that such authority is critical during a public health emergency
