The U.S. Food and Drug Administration (FDA) announced Wednesday that it will relax certain rules for approving low-cost versions of some high-priced medications, in an effort to speed up access to ...
But last week, those words took on the force of law. On Tuesday, Texas Attorney General Ken Paxton filed a lawsuit against ...
The U.S. Food and Drug Administration announced it will relax certain rules for approving low-cost versions of some high-priced medications to reduce costs.
The FDA’s new draft guidance aims to make the approval process faster and less burdensome by limiting the need for ...
Clinical Trials Arena on MSN
FDA looks to simplify biosimilar development with new draft guidance
The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...
The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex ...
The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative ...
The agency announced moves to cut regulatory obstacles for the makers of biosimilar drugs, which are akin to generics and may ...
AI and accelerated computing are transforming the bio/pharmaceutical sector by addressing organizational, technological, and ...
Some of the most expensive drugs currently in use are gene therapies to treat specific diseases, and their high cost limits ...
Eva-Maria Hempe, NVIDIA, says bio/pharma must centralize AI strategy, tackle silos, prioritize process integrity, and balance quick wins with long-term drug design goals.
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