The FDA has been forced to delay an approval decision for a drug developed by Spectrum Pharmaceutical due to travel challenges.
The company reported this week that the agency has been unable to schedule an inspection of its manufacturing facility located in South Korea — a required part of the approvals process.
Rolontis, the drug the company is hoping to have OK’d, was developed to treat the loss of white blood cells in cancer patients that have taken chemotherapy or radiation therapy.
In March, the FDA announced its plan to postpone most foreign inspections due to the COVID-19 outbreak. The agency has since laid out criteria for conducting “mission critical” inspections and warned that there may be delays in completing needed inspections for drug approvals.
Spectrum said it is working with the FDA to schedule an inspection and said that the process might delay approval for up to six months.
Read the Reuters report.
