6 July 2024 - The Orphan Drug Act was enacted in the United States in 1983 in response to growing awareness ...
2 July 2024 - The FDA’s rare paediatric disease priority review voucher program, which has been providing incentives for lifesaving innovations ...
7 May 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...
21 November 2023 - Most people probably assume that all prescription drugs on the US market have been proven effective in ...
30 January 2023 - A FDa official on Monday gave more clues for how the agency plans to wield new authority ...
25 January 2023 - Congress just boosted the FDA’s authority over the post-market clinical trials that are a condition of ...
18 January 2023 - A FDA program markedly cut the time and cost of bringing to market new drugs, without ...
9 January 2023 - This past year featured many significant developments in the prescription drug policy area, most notably the passage ...
17 November 2022 - Makena highlights need to make system more nimble. ...
14 October 2022 - The decision by law makers to drop regulatory reforms of dietary supplements, cosmetics and diagnostic tests from ...
21 September 2022 - To address ongoing concerns about the implementation of the FDA’s accelerated approval pathway in oncology, a ...
17 August 2022 - The FDA uses expedited approval of drugs to speed the development and assessment of drugs that address ...
23 June 2022 - It was precisely 30 years ago, in 1992, that the FDA established the accelerated approval program ...
27 May 2022 - As practicing physicians, approval by the U.S. FDA reassures us that the treatments we prescribe our patients ...
4 May 2022 - House lawmakers are moving a little closer toward cracking down on drugmakers that game the FDA’s ...