Every year, thousands of Americans die because the Food and Drug Administration denies them access to life-saving medical devices. And things aren't looking up. For all but the riskiest devices, manufacturers have to submit a "pre-market notification," which is supposed to be approved or disapproved within 90 days. At first, these were routinely approved, but that changed after 1990. Thanks to the Safe Medical Devices Act of 1990 and the Medical Devices Amendments of 1992, the FDA spends more time reviewing applications than ever before. And Commissioner David Kessler has been calling for increased "consumer protection" (i.e., regulatory power) ever since he was appointed in 1990. Now he wants "user fees" to increase Device Center staff–$3,200 for run-of-the-mill devices and up to $50,000 for riskier ones.
Paul Krugman Thinks Holding Religious Services During the COVID-19 Pandemic Is Like 'Dumping Neurotoxins Into Public Reservoirs'
The New York Times columnist misconstrues the issues at stake in the challenge to New York's restrictions on houses of worship.
SCOTUS Blocks New York's COVID-19 Restrictions on Houses of Worship, Saying They Are Not 'Narrowly Tailored'
Gov. Andrew Cuomo described his policy as a "fear-driven response," cut by a "hatchet" rather than a "scalpel."
Penguin Random House Employees Broke Down in Tears at Thought of Publishing Jordan Peterson's Next Book
"He is an icon of hate speech and transphobia."
Denver Mayor Michael Hancock Urged People Not To Travel for Thanksgiving Shortly Before Boarding His Flight
The mayor is traveling to Mississippi to spend the holiday with his wife and daughter.