Tag: Food & Drug Administration
Bayer Stops U.S. Sale of Essure Birth Control Implant
Problems with device include chronic pain and perforations of the uterus and fallopian tubes
FDA Recalls Drugs Containing Active Ingredient Valsartan
All lots of non-expired products that contain valsartan supplied by Zhejiang Huahai being recalled
Trials Supporting FDA Approval of Breakthrough Drugs Examined
Pivotal trials supporting these approvals often lack randomization, double-blinding, control groups
Fake FDA Warning Letters Being Sent to Consumers
Letters accuse consumer of drug violations based on a review of their parcels and social media accounts
FDA Approves First Drug to Treat Smallpox
New treatment offers additional option should smallpox ever be used as a bioweapon
FDA Requires Safety Label Changes for Fluoroquinolones
Changes will describe hypoglycemic coma and clarify and identify mental health side effects
High Rates of Salmonella Contamination ID’d in Kratom
As of end of May 2018, 199 cases of salmonellosis ID'd that were linked to kratom consumption
FDA Permits Marketing of Devices to Create Arteriovenous Fistula
Two devices designed to create arteriovenous fistula in patients with CKD in need of hemodialysis
FDA Approves Epidiolex for Severe Forms of Epilepsy
Cannabidiol oral solution approved for patients 2 and older with Lennox-Gastaut and Dravet syndromes
FDA Approves Continuous Glucose Monitoring System
Eversense CGM, which has fully implantable sensor to detect glucose, approved for adults with diabetes
