Global agencies have collaborated to create parallel regulatory approval solutions to help get drugs to patients more quickly. Experts who have used these schemes say that while these schemes have ...
The Food and Drug Administration (FDA) on Monday announced a new proposal for flexible drug approval pathway treatments ...
The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...
In the second part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss the regulatory pathways for biological products under Section 351 of the Public Health Service ...
Late on Wednesday, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and Center for Biologics Evaluation & Research (CBER) Director Vinay Prasad published an article in the New England ...
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