FDA Postponed Foreign Reviews Citing Coronavirus Epidemic

The U.S. FDA has announced the suspension of most foreign assessments for drug, food, and medical devices abroad through April. The federal agency has announced the news citing the rapidly spreading coronavirus across America. So overseas manufacturing facilities will not gain approvals for the upcoming few weeks. Reportedly, the FDA will not perform regular inspections but may examine facilities where production difficulties may exist or complete so-called pre-approval review. Such investigation refers to a plant that a company would use to make a drug, which the agency will study each case. The statement arrives as the government tries to deal with the fast-growing coronavirus cases. It is the latest indication of how the disease is distressing everyday routines and having a negative effect on economies.

Stephen Hahn, FDA’s Commissioner, said they are aware of how this effort may affect other FDA liabilities, like product application assessments. He added they would be attentive and keep a close eye on the situation. Even more, the federal agency will attempt to lessen probable impacts from this epidemic in association with the entire federal government. Hahn noted the decision relies on several factors, like State Department’s several cautions which stop American government workers from traveling. Apart from this, the effort depends on travel restrictions which other countries have imposed on foreign visitors.

Well, it is not the first time the agency has canceled reviews. Formerly, the FDA has had terminated physical checkups in China at the start of February. Since then, the agency has maintained that it has various means to continue performing inspections. It also includes product sampling as well as physical examinations at the border. Reviewing a company’s former alliance and using the information offered by the governments or companies of foreign countries are some other aspects. Janet Woodcock, the Director of FDA’s Center for Drug Evaluation and Research, said the epidemic of respiratory disease triggered by a new coronavirus, which started in China, is spreading to other nations. She added as a precaution, FDA is controlling domestic travel and stopping official foreign tours.