The U.S. Food and Drug Administration (FDA) announced a new program on Tuesday to speed up the approval process for certain new medicines.
This initiative, called the Commissioner’s National Priority Voucher program, aims to help drugs that support important health goals in the United States get reviewed faster.
Normally, the FDA takes about 10 to 12 months to review a drug application. Under this new program, the review time could be shortened to just one to two months. This faster process will help bring new treatments to patients more quickly.
The program works by creating a special team of experts from different FDA offices. Instead of sending a drug application through many separate departments, this team will review all the information together.
They will meet in a one-day session, similar to a “tumor board” used by doctors to make quick, important decisions about patient care.
FDA Commissioner Dr. Marty Makary explained that this team approach will reduce delays and inefficiencies. “The ultimate goal is to bring more cures and meaningful treatments to the American public,” he said. Dr. Makary, who is also a surgical oncologist, said the program uses a method like the one doctors use when making life-or-death decisions.
To qualify for this faster review, drug companies must meet certain criteria. Their drugs should address urgent health problems, offer new and innovative cures, meet important public health needs, or help increase drug manufacturing in the U.S. for national security reasons.
Companies must submit key parts of their drug application, including details about how the drug is made and labeled, at least 60 days before sending the full application. They also need to stay in close contact with the FDA and respond quickly to any questions during the review.
This new program could help speed up the availability of important medicines that improve health and save lives across the country.
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