Tag: Food & Drug Administration
FDA Oversight of Clinical Trials Described as ‘Grossly Inadequate’
Article describes inadequate oversight relating to development of COVID-19 vaccines and predating the pandemic
FDA Approves Drug Combo for Metastatic Non-Small Cell Lung Cancer
Approval is for tremelimumab in combination with durvalumab and platinum-based chemotherapy
FDA Panel Votes for Removal of Drug Meant to Prevent Preterm Births
FDA, Company Square Off in Hearing Over Drug Meant to Prevent Preterm Births
FDA officials want to withdraw the drug because of a lack of evidence of its efficacy and because of side effects
Most Safety Signals Reported to FDA Lead to Regulatory Action
Regulatory actions by the FDA were corroborated by at least one relevant published research study for 17 of 57 resolved safety signals
FDA Admits Flaws in Response to Infant Formula Shortage
Problems highlighted in report include outdated data-sharing systems, below-normal staffing and training for food inspectors
In Rare Move, FDA Panel Gives Support to Controversial ALS Drug in Second Review
Medication combines a dietary supplement used in traditional Chinese medicine with an existing prescription drug for liver disorders
FDA Approves SPEVIGO for Generalized Pustular Psoriasis Flares
The monoclonal antibody infusion is approved for use in adults
FDA Approves First Treatment for Acid Sphingomyelinase Deficiency
The enzyme replacement therapy is administered through an intravenous infusion and approved for both adult and pediatric patients
FDA Warns of Dangers From Skin-Lightening Creams
Potentially harmful ingredients are hydroquinone or mercury, according to the agency
