Blog
RSS FeedPosted by Michael Wonder on 10 Oct 2021
New FDA chief can't come soon enough for beleaguered agency
8 October 2021 - One of the leading agencies in the government’s fight against COVID-19 is finally on the verge of ...
Posted by Michael Wonder on 07 Oct 2021
The FDA should better regulate medical algorithms
7 October 2021 - Most do not require the agency’s approval, and those that do often don’t require clinical trials. ...
Posted by Michael Wonder on 07 Oct 2021
FDA still without a permanent leader as clock ticks down on acting head
7 October 2021 - The clock is ticking down on the time President Joe Biden has to appoint a permanent ...
Posted by Michael Wonder on 07 Oct 2021
FDA issues final order and guidance on surgical staplers and staples for internal use
7 October 2021 - Today, the U.S. FDA announced several actions related to surgical stapler and staple regulation and safety. ...
Posted by Michael Wonder on 05 Oct 2021
FDA’s naming rule for biosimilars has undermined Congress and health care
4 October 2021 - I recently tried to order white blood cell growth factor (pegfilgrastim) biosimilar for one of my ...
Posted by Michael Wonder on 02 Oct 2021
FDA, sponsors advance reliance on real world data & evidence
2 October 2021 - Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional ...
Posted by Michael Wonder on 26 Sep 2021
FDA tweaks biosimilar application review program
25 September 2021 - The FDA has struggled during the COVID-19 pandemic to conduct timely reviews of biosimilar approval applications. ...
Posted by Michael Wonder on 23 Sep 2021
A middle ground for accelerated drug approval—lessons from aducanumab
23 September 2021 - The accelerated approval by the US FDA of Biogen’s monoclonal antibody aducanumab (Aduhelm) for treatment of patients ...
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 19 Sep 2021
Should regulatory authorities approve drugs based on surrogate outcomes?
16 September 2021 - The aducanumab controversy is the latest example of surrogate outcomes failing to predict clinically important outcomes. ...
Posted by Michael Wonder on 16 Sep 2021
Raising the bar for using surrogate outcomes in drug regulation and health technology assessment
16 September 2021 - Surrogate outcomes provide no guarantee of clinical benefit, and Dalia Dawoud and colleagues argue they should ...
Posted by Michael Wonder on 15 Sep 2021
FDA, EMA launch complex generic, hybrid product advice pilot
15 September 2021 - The US FDA and the EMA on Wednesday launched a new pilot aimed at giving parallel ...
Posted by Michael Wonder on 15 Sep 2021
Aduhelm backlash threatens to reverse progress in FDA’s reviews of rare and ultra-rare disease drugs
14 September 2021 - The FDA’s approval of Aduhelm to treat Alzheimer’s disease has unleashed criticism about the decision and ...
Posted by Michael Wonder on 14 Sep 2021
A court decision on “skinny labeling” another challenge for less expensive drugs
13 September 2021 - Brand name drugs, such as apixaban (Eliquis) and lenalidomide (Revlimid), account for approximately 80% of US drug ...
Posted by Michael Wonder on 10 Sep 2021
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
9 September 2021 - The researchers set out to investigate the regulatory handling of cancer drugs that were granted accelerated approval ...