FDA APPROVAL ON DRUG, VACCINE POSSIBLE IN 40 DAYS OR LESS WITH EUA
Dr. Jaime Montoya of the Philippine Council for Health Research and Development (PCHRD) said Food and Drug Administration (FDA) (FDA) approval of a drug or vaccine can be expected in 40 days or less now that it is allowed to issue emergency use authorization (EUA).
Without EUA, Montoya said the process usually takes about six months.
“Yung normal na proseso, yung walang EUA, umaabot ng anim na buwan bago aprubahan,” Montoya said.
“Kung may EUA, according to FDA, puwedeng 40 days or less pa, depende kung gaano kakumpleto ang mga dokumentong isa-submit [ng developer].” He added.
He added that the process will also be faster for drugs or vaccines that have been given EUA in other countries.
Approval, however, is not automatic, according to Montoya, stressing that the FDA can reject drugs or vaccines that pose more risks than benefits.