Will Boggs, MD |
Medications for serious or life-threatening conditions may receive accelerated approval from the U.S. Food and Drug Administration (FDA) by showing an effect on surrogate measures that are reasonably likely to predict a treatment’s clinical benefit. Post-approval confirmatory drug trials are then required to determine whether or not these effects translate into clinical improvements. In recent…
In recent years, the number of drugs to receive accelerated FDA approval has increased. A new study examined whether these drugs have demonstrated efficacy in post-approval trials…
Over the past few years, biosimilars and other new drugs have been introduced to treat rheumatic illnesses. Some of the conditions we treat have numerous drug options, others have few or only off-label options. This series, “Rheumatology Drugs at a Glance,” provides streamlined information on the administration of biologic, biosimilar and small molecule inhibitor drugs…
Three FDA representatives discuss new drug indications, safety precautions and label changes, & an emergency program to rapidly evaluate existing immunomodulating therapies for use in COVID-19 patients.