The Accelerated Approval Integrity Act of 2022 (H.R. 6963) aims to remove loopholes in the Food and Drug Administration’s accelerated approval pathway. The bill, however, fails to adequately consider the whole picture, and may inadvertently remove medications that simply can’t complete confirmatory trials within the narrow timeframe allowed.
U.S. drugmaker Pfizer Inc. said the company’s Chief Executive Albert Bourla plans to testify during February 2018 at a Senate hearing examining rising prescription drug prices.
November 18, 2015By Alex Keown, BioSpace.com Breaking News Staff WASHINGTON – The U.S. Food and Drug Administration (FDA) is looking to shore up loopholes that allow companies, including embattled Theranos, to market certain diagnostics tests without having to go through the regulatory process, theverge reported late Tuesday. During a Tuesday hearing of the Energy […]