Drugs selected for the FDA’s new Commissioner’s National Priority Review Voucher pilot program could receive a regulatory decision in two months or less. Qualifying product candidates must address a national priority, such as filling an unmet medical need or boosting domestic drug manufacturing.
FDA Commissioner Marty Makary said publishing complete response letters recognizes public interest in the transparency and credibility of agency decision-making about drugs. He also said the move complies with an executive order that covers the communication of scientific data.
Incorporating aquatic therapy can enhance patient outcomes and shorten recovery times for health care professionals. In the Chicago suburbs, the demand for such programs is rising.
To be eligible for the FDA’s new Commissioner’s National Priority Voucher program, a drug must meet certain national health interests. Qualifying medicines could be reviewed in one to two months, down from the standard 10 months to a year.