Food and Drug Administration Approval of Laboratory Tests

CCR Perspectives in Drug Approval Radium Ra 223 Dichloride Injection: U.S. Food and Drug Administration Drug Approval Summary

OnMay15, 2013, theU.S. FoodandDrugAdministration (FDA) approved radiumRa223dichloride (Ra223; Xofigo injection; Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castrationresistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The FDA reviewwas based on clinical trial BC1-06, which randomly allocated patients (2:1) to eit...

US Food and Drug Administration and design of drug approval studies.

The US Food and Drug Administration Cardiorenal Advisory Panel and the drug approval process.

New chemical entities developed by the pharmaceutical industry as potentially useful drugs undergo extensive preclinical evaluation followed by clinical trials to evaluate efficacy and safety in human subjects. In the United States, the Food and Drug Administration (FDA) is charged with evaluating requests from pharmaceutical sponsors for approval to market new drugs or to expand indications fo...

United States Food and Drug Administration Drug Approval summary: Gefitinib (ZD1839; Iressa) tablets.

On May 5, 2003, gefitinib (Iressa; ZD1839) 250-mg tablets (AstraZeneca Inc.) received accelerated approval by the United States Food and Drug Administration as monotherapy for patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies. Information provided in this summary includes chemistry manufacturing and controls...

Radium Ra 223 dichloride injection: U.S. Food and Drug Administration drug approval summary.

On May 15, 2013, the U.S. Food and Drug Administration (FDA) approved radium Ra 223 dichloride (Ra-223; Xofigo injection; Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The FDA review was based on clinical trial BC1-06, which randomly allocated patients ...