An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
3don MSN
Legal questions swirl around FDA's new expedited drug program, including who should sign off
The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...
The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...
A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...
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