The U.S. Food and Drug Administration (FDA) today released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)(1) , a sweeping guidance that codifies multiple regulatory ...
The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...
In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products ...
The FDA Center for Devices and Radiological Health (CDRH) maintained a brisk pace after a record-breaking 2023. Among other activities — most notably, granting marketing authorization to novel devices ...
The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...
State and federal officials will now have unified federal standards guiding produce inspections under new guidelines being ...
After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...
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