Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 06 Sep 2021
Congress “concerned by apparent anomalies” around FDA’s approval of Aduhelm
6 September 2021 - Congress demands more information from the FDA on its controversial approval of Biogen’s Alzheimer’s drug and its ...
Posted by Michael Wonder on 05 Sep 2021
America desperately needs a much better FDA
2 September 2021 - In the early 1960s, an unflappable FDA scientist named Frances Kelsey spared the nation from the horrors ...
Posted by Michael Wonder on 02 Sep 2021
House Committees demand FDA records on Alzheimer’s drug approval
2 September 2021 - The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter. ...
Posted by Michael Wonder on 02 Sep 2021
FDA reaches milestone in competitive generic therapy drug approvals
2 September 2021 - This week, the FDA reached the milestone of approving more than 100 generic drug applications with a ...
Posted by Michael Wonder on 02 Sep 2021
FDA to hold Advisory Committee meeting to discuss Pfizer-BioNTech’s application for COVID-19 booster
2 September 2021 - Today, the U.S. FDA announced a virtual meeting of its Vaccines and Related Biological Products Advisory ...
Posted by Michael Wonder on 01 Sep 2021
FDA requires warnings about increased risk of serious heart related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions
1 September 2021 - Based on a completed U.S. FDA review of a large randomised safety clinical trial, we have concluded ...
Posted by Michael Wonder on 26 Aug 2021
Biden Administration likely to approve COVID-19 boosters at six months
26 August 2021 - Pfizer, BioNTech have requested clearance for COVID-19 vaccine boosters that an official said could be administered six ...
Posted by Michael Wonder on 24 Aug 2021
FDA, drug makers propose new pilots aimed at speeding rare disease drugs, as part of user fee update
23 August 2021 - The FDA and the drug industry have jointly agreed to create several new pilot programs aimed ...
Posted by Michael Wonder on 23 Aug 2021
Estimands, estimators and estimates
23 August 2021 - The primary goal of most randomised clinical trials is to draw conclusions about the effect of a ...
Posted by Michael Wonder on 20 Aug 2021
Acting FDA Chief Janet Woodcock ruled out as Biden nominee
19 August 2021 - Woodcock faced backlash over controversial Alzheimer’s drug. ...