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.

Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...

Through its recently unveiled Priority Voucher program, the FDA seeks to accelerate the review process for companies that ...

It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...

FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...

The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns ...

Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews.

FDA to offer faster drug reviews to companies promoting ‘national priorities’ The FDA already has a variety of programs designed to speed up drug reviews, but they all have fairly strict ...

WASHINGTON – U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting “the health interests of Americans,” under a new initiative ...