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.

Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more ...

On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to participate in a new pilot program called Support for ...

In the first part of this Q&A, Kathy Oubre, MS, discusses how likely it is that the most favored nation executive order will lead to price reductions in prescription drugs.

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.

Gilead Sciences is seeking to boost prices significantly for several treatments that are widely distributed by state AIDS Drug Assistance Programs.

Of the additional $15.25 million in funding appropriated for the FDA’s food safety programs, $1 million was allocated to enhance the CFSAN’s ability to ensure contaminated food is detected and ...

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.

Drugs reviewed by the FDA under programs intended to speed drug development were approved nearly a year more quickly than drugs reviewed through the agency's normal processes.