In a report published in Hepatology, scientists from the FDA’s Division of Antiviral Products in the Center for Drug Evaluation and Research (CDER) have provided a brief overview of the FDA’s scientific approaches and regulatory processes designed to accelerate the approval of drugs to treat hepatitis C virus (HCV).
The decision to publish the paper was made because of concerns regarding the efficacy of new, interferon- and ribavirin-free regimens that have gained traction in the drug marketplace. Publishing the paper should clear up some concerns that the drugs are not being properly evaluated, the authors write.
“This paper intends to provide increased transparency to various stakeholders about FDA’s scientific approaches and regulatory processes that supported drug development and marketing approval of [direct-acting antiviral agents] for the treatment of hepatitis C,” writes lead author Dr. Poonam Mishra, a deputy director in CDER.
Read the full article in Hepatology (doi:10.1002/hep.27880).