The US Food and Drug Administration (FDA) plans to hold a public meeting in June 2013 to discuss its progress in advancing regulatory science for generic drug products and solicit feedback on its ...
The FDA has undergone a series of major policy shifts under Marty Makary, MD, MPH, who recently resigned from his position as ...
The Food and Drug Administration announced the launch of a new program to fast-track agency approvals for drug manufacturers working on products that could cure chronic disease, prepare for a pandemic ...
Forbes contributors publish independent expert analyses and insights. Tor Constantino is an ex-reporter, turned AI consultant & tech writer. In a landmark for U.S. public health digital transformation ...
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 ...
The FDA named the first nine products to undergo a new expedited review process that takes 1 to 2 months, the agency announced on Thursday. The nine companies selected to participate in the FDA ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
The FDA has introduced models intended to accelerate rare disease drug development, but recent reversals of guidance from the ...