Blog
RSS FeedPosted by Michael Wonder on 11 Jan 2022
FDA approved more first in class drugs, gave more accelerated approvals in 2021
7 January 2022 - The US Food and Drug Administration’s Center for Drug Evaluation and Research approved 50 new drug therapies ...
Posted by Michael Wonder on 04 Dec 2021
Reforms needed for FDA’s regulation of medical devices
3 December 2021 - Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to complex ...
Posted by Michael Wonder on 21 Sep 2021
U.S. Food and Drug Administration reasoning in approval decisions when efficacy evidence is borderline (2013–2018)
21 September 2021 - The U.S. FDA has substantial flexibility in its approval criteria in the context of life-threatening disease and ...
Posted by Michael Wonder on 13 Aug 2021
Congress should fix FDA’s accelerated approval program for the next 30 years
12 August 2021 - The FDA's approval of the Alzheimer’s drug Aduhelm has sparked a broader debate on the merits ...
Posted by Michael Wonder on 08 Aug 2021
US tropical disease priority review vouchers: lessons in promoting drug development and access
6 August 2021 - The COVID-19 global pandemic has devastated lives and economies. It has served as a reminder of how ...
Posted by Michael Wonder on 04 Aug 2021
FDA regulation and approval of medical devices: 1976-2020
3 August 2021 - US law generally requires testing of high-risk medical devices prior to approval, as well as pre-market evaluation ...
Posted by Michael Wonder on 02 Aug 2021
FDA’s Pazdur challenges attack on accelerated approval program
2 August 2021 - In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill ...
Posted by Michael Wonder on 31 Jul 2021
FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway
30 July 2021 - Criticisms of the US FDA’s accelerated approval process have resurfaced after the recent approval of aducanumab ...
Posted by Michael Wonder on 14 Jul 2021
Harvard doctor urges FDA reforms after Biogen Alzheimer nod
13 July 2021 - Curtail biomarker use for clearance, Kesselheim writes in JAMA. ...
Posted by Michael Wonder on 30 Apr 2021
Bristol Myers Squibb statement on FDA Advisory Committee meeting on Opdivo post sorafenib hepatocellular carcinoma U.S. indication
29 April 2021 - As part of its industry-wide review of accelerated approvals in oncology without confirmatory benefit, the U.S ...
Posted by Michael Wonder on 28 Apr 2021
FDA Advisory Committee votes in favour of maintaining accelerated approval of Genentech’s Tecentriq for PD-L1 positive, metastatic triple negative breast cancer
27 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 7 to 2 in favour of ...
Posted by Michael Wonder on 18 Jan 2021
FDA sped progress for most of 2020's novel drugs
14 January 2021 - Most novel drugs approved by the US FDA in 2020 made their way through the approvals process ...
Posted by Michael Wonder on 14 Apr 2020
Pharmacologic treatments for coronavirus disease 2019 (COVID-19): a review
13 April 2020 - The pandemic of coronavirus disease 2019 (COVID-19) caused by the novel severe acute respiratory syndrome coronavirus 2 ...
Posted by Michael Wonder on 20 Feb 2020
Serving public health paramount in a successful 2019 for FDA’s generic drug program
19 February 2020 - Safe, effective, high-quality generic drugs play a vital role in the U.S. health care system. ...
Posted by Michael Wonder on 15 Jan 2020
Reform at the FDA—in need of reform
14 January 2020 - On 23 December 2016, the US FDA announced the approval of nusinersen, the first drug for the ...