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Stem cell clinics should file INDs immediately, patients looking for stem cell treatments should only do so for those offered under INDs, patients should ask for informed consent, not pay for the treatment, and report adverse events. Or so FDA would want to see. In an article last week in the Journal of American Medical … Read more

In a rare criticism of FDA’s requirements for clinical trials, two former commissioners of FDA, Scott Gottlieb and Mark McClellan, argue that FDA should allow practical trial designs of the kind used to evaluate dexamethasone treatment in COVID patients in the UK where data collection was “limited to most important measures of disease severity and … Read more

In a first of its kind, this week FDA approved a video game as a medical device for the treatment of children with ADHD. Besides the happy children who have one more reason to play more video games (as if they needed one), this presents a new opportunity for game developers. With this decision, FDA … Read more

More than 1300 Chinese companies used one fictitious address and US Agent information to register with the FDA and exported products to the US that did not meet US requirements, and it may be the tip of an iceberg. Preliminary searches on FDA’s database for registered device manufacturers include 13,751 Chinese device companies, which represent … Read more

A much-publicized data on the risk of chloroquine therapy in COVID had to be retracted due to questions about the underlying data creating much more than an embarrassment for the authors and the publishers. It once again highlighted how in the race to publish first; journals cut corners in the peer-review. There were several obvious … Read more

This week Innovio Pharmaceuticals and its manufacturing vendor, VGXI, got into a public disagreement regarding the terms of their contract which is a primer on vendor management for any company working with vendors in mission critical roles. Innovio would like to move commercial production of the most promising product in its portfolio to new vendors … Read more

About 2 out of 3 cancer drug approvals between 1992 and 2019 were based on surrogate endpoints and about 1 out of 3 surrogate endpoints were used first-time for market approval. A recent survey challenges the wide use of surrogate endpoints over direct measures such as overall survival. The authors found that about half of … Read more

This week FDA re-released a free tool for electronic informed consent to be used in clinical trials as an alternate to conventional paper-based informed consents. This is to help investigators obtain informed consent during the pandemic. But the tool seems to be of very limited functionality. It is hard to know if being free is … Read more

Tests that detect antibodies to the coronavirus in blood, serum and plasma have emerged as the key players in creating a feel-safe environment for re-opening our lives post-pandemic, and present an interesting safety and effectiveness paradigm for regulatory agencies. Antibody detecting tests can be designed to give results in minutes, do not require sophisticated equipment … Read more

FDA announced this week that it will no longer hold in-person meetings. All previously scheduled in-person meetings have been converted to phone meetings or written responses only. Many meeting requests will be delayed and may be denied. Among the impacts of the pandemic, this change will perhaps bite the most for the regulated industry that … Read more