Prashant Kumar Sinopharm, the Chinese government owned company announced that 30 of its employees, including some in senior management roles, were the first to receive its experimental Covid vaccine. And this would be legal even in the US. It is often assumed, incorrectly, that the regulations prohibit employee participation in company-sponsored clinical trials. On the contrary, under … Read more
FDA announced earlier this week that the domestic GMP inspections would commence on Monday, 20 July. However, there would still be several conditions that must be met before FDA inspectors travel to a manufacturing site and FDA would allow several concessions to the site being audited such as no-unannounced visits, using PPEs during the visit … Read more
With the announcement of positive results from a small clinical trial for its experimental Covid vaccine this week, Moderna set the stage for what to expect in the next 2-3 months. Moderna may be in the news more than others, but others are not behind. Oxford-Astra Zeneca announced the start of a 10,000 patient multi-national … Read more
The most expensive component of the development program for any new medical product is the clinical trials, particularly the pivotal clinical trials, that could recruit hundreds if not thousands of patients per trial and take 1-2 years to complete. Most industry estimates claim that the pivotal clinical trials account for more than 70% of the … Read more
Well, not literally, but the various clinical trials being scheduled this summer to evaluate the various vaccine and therapeutic agents for COVID-19 have created a stiff competition for volunteers among the various contenders. Of the more than 130 vaccines for COVID-19 in development, about 17 vaccines are currently in human trials, of which about 6 … Read more
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
