Predicting The FDA’s Future image

Health Affairs , January 2016, Vol. 35 No. 1
Jessica Bylander, reviewing book edited by I. Glenn Cohen (Faculty Director) and Holly F. Lynch (Executive Director)

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From the review:

What will regulation of drugs and medical devices by the Food and Drug Administration (FDA) look like in the coming decades? The answer to this question should interest not only drug and device companies, which are deeply affected by the agency’s rules and regulations, but also the American public, whose access to and experience with new medical products will hinge on how FDA regulation evolves. Though knowledgeable writers have weighed in before on how the FDA should adapt to a changing health care environment and rapid innovation on the part of the drug and device industries, the topic remains ripe for discussion. With any luck, new ideas and compelling recommendations might actually guide the agency’s next steps.

It was to this end that Holly Fernandez Lynch and I. Glenn Cohen gathered a group of academics, government officials, health care practitioners, and industry representatives for a conference at Harvard Law School in 2013 to evaluate how well the FDA has kept up with the evolving world of drugs and devices, and to […]

holly fernandez lynch i. glenn cohen