Regular drug reviews take about 10 months. Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to “challenge assumptions” and rethink procedures.

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

FDA’s long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

FDA to offer faster drug reviews to companies promoting ‘national priorities’ June 17, 2025 | Associated Press ...