FDA reviewed many published research studies, including both nonclinical and clinical data. Nonclinical Studies We reviewed published nonclinical studies showing that early exposure to anesthetic drugs […]

[12-20-2017 ] A U.S. Food and Drug Administration (FDA) review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

[ 4-8-2016 ] The U.S. Food and Drug Administration (FDA) is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use […]

FDA approved changes to the DOVATO (dolutegravir/lamivudine) product labeling to include a new indication and provide longer term (96 week) safety and efficacy data from the […]

Update: 3/23/2011 FDA has determined an osteoporosis and fracture warning on the over-the-counter (OTC) proton pump inhibitor (PPI) medication “Drug Facts” label is not indicated at […]

Reference #: FEI 1000418405 Product: Drugs Recipient: Recipient Name Mr. Luis Solera Blasco Recipient Title Chief Executive Officer Bioiberica, SAU Carrer Antic Cami de Tordera 109-11908389 […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Luis Solera Blasco Recipient Title Chief Executive Officer Bioiberica, SAU Plaza Francesc Macia, 708029 Barcelona BarcelonaSpain […]

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER January 16, 2025 RE: 698165 Dear Michael […]