The FDA already authorizes the use of experimental drugs under what’s called “compassionate use,” for people with no other ...
Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...
A panel of physicians, biotech leaders and patient advocates took aim at the FDA during a Senate hearing Thursday on how the ...
Psychedelic drug development can still benefit from the FDA Commissioner’s National Priority Review Voucher Pilot Program, though the CNPV designation was not given to Compass Pathways’ synthetic ...
The FDA has proposed new guidelines to expedite the approval of customized treatments for rare diseases, creating a streamlined pathway for bespoke therapies that could address unmet medical needs.
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FDA commissioner raises concerns about US pharma lagging behind China in drug development
Makary urged the Trump administration to partner with the pharmaceutical industry. ・The senior official is of the opinion ...
Strengthening post-market review requires more than new tools—it requires sustained scientific engagement. For all of FDA’s ...
The 300,000-square-foot MGS facility has more than 100 injection molding machines and 140,000 square feet of ISO Class 8 ...
The FDA released a much-anticipated draft guidance on how makers of rare disease genetic medicines can leverage a platform ...
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