Regulatory issues in the evaluation of antimetastatic and other novel anticancer therapies.
This article outlines some of the complexities and challenges confronting researchers and the US Food and Drug Administration (FDA) in the area of evaluation of antimetastatic and other novel anticancer therapies. The scientific regulatory matrix utilized by the FDA is outlined. Subsequently, the complications encountered when designing and interpreting studies of antimetastatic drugs are described, and finally changes in the regulatory landscape both within the USA and internationally are considered.
Friedman
M A
MA
US Food and Drug Administration, Rockville, MD 20857, USA.
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D009362:Neoplasm Metastasis / Q000188:drug therapy* / Q000517:prevention & control; D014481:United States; D014486:United States Food and Drug Administration
D000970:Antineoplastic Agents