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Us FDA: approved Gilead's approval of an orphan drug.

HOME    Market News    Us FDA: approved Gilead's approval of an orphan drug.

The US Food and Drug Administration (FDA) announced on its website on March 23 that the FDA approved Gilead inc. 's Ridsiwe orphan drug for the treatment of COVID - 19. An orphan drug is a pharmaceutical preparation specifically designed to treat a rare disease, itself known as an orphan disease. Most importantly, the United States provides a fast-track to new drug applications for orphan drugs, with a variety of accelerated review policies for clinical trial applications. This means that once the orphan drug is certified, the process of registering the drug for marketing will be greatly accelerated. The company is now moving from a "compassionate use" system to an expanded use plan. Some experts pointed out that the FDA adopts the "orphan drug identification first, marketing approval later" approach for the registration of orphan drugs. In the future, once the efficacy of Reidsivir has been proved by clinical trials, the FDA can approve Reidsivir through the form of "urgent authorization".

2020年3月27日 17:09