FDA's plan to boost cheaper copycat drugs could stall at the patent office
The FDA's push for lower-cost medicines looks good on paper, but the patent office under President Trump may be going in the opposite direction.
Fierce Biotech
UPDATED: Prasad, Makary unveil new FDA path for accelerating custom gene editing therapies
In a highly anticipated article, FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., outlined a novel regulatory pathway that could trigger a seismic shift in how bespoke gene editing therapies are developed and approved.
Benzinga.com
STAT+: How the first nine drug companies won priority review vouchers from Marty Makary's FDA
WASHINGTON — Commissioner Marty Makary wants the Food and Drug Administration to move more quickly. The launch of a new priority review voucher program in June was no exception. The agency promised winners a one-to-two month review of their drug ...
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