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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 ...
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.
Through its recently unveiled Priority Voucher program, the FDA seeks to accelerate the review process for companies that ...
The New Brunswick, N.J., pharmaceutical giant on Thursday said the application covers TAR-200 for the treatment of patients with Bacillus Calmette-Guerin-unresponsive high-risk non-muscle invasive ...
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 ...
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 ...
The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump administration priorities for Americans' health.