iwewlkws Starting this week, the Premarket Approval (PMA) applications can also be submitted electronically to the FDA using the eSTAR format. FDA released an update of the eSTAR template which now includes the PMA application. It is critical to review the utility of the eSTAR template for creating FDA-acceptable PMA applications. The eSTAR template is a … Read more
According to the FDA, all clinical trials that should be compliant with the clinicaltrials.gov regulations are already compliant. In a surprising blog this week, the FDA Commissioner pointed out the major flaw in the complaint that most clinical trials are not compliant with clinical trial reporting requirements by stating that only 15% of the trials … Read more
This week FDA made an explosive announcement that there are reports of new cancers in patients treated with several approved CAR-T therapies. Although the FDA added the disclaimer that the benefit of these treatments still outweighs the risk of the same, the news is sure to rattle patients who received these treatments over the last … Read more
A new proposed rule intends to reclassify several wound dressings from 510k to Class III PMA medical devices based on the use of certain types of antimicrobials in these products. FDA will also create new product codes for several wound dressings that are currently designated as pre-amendment unclassified medical devices. Many of these wound dressings … Read more
Chat GPT can generate volumes of credible looking misinformation in minutes raising concerns about its ability to maximize the impact of disinformation generated by malicious players. Such disinformation is almost impossible to counter since accurate and credible information can be easily drowned in seemingly unlimited false and misleading information creating a nightmare for health authorities … Read more
Since its inception a little more than 10 years ago, the Breakthrough Therapy Designation (BTD) has become the most recognized indication of the FDA’s strong support for the therapeutic potential of a new drug. However, a BTD designation is hard to get; about two-thirds of the requests for BTD are denied or withdrawn by the … Read more
When the FDA refuses to issue export certificates for certain medical devices, the requesters can appeal the process. A new guidance document released this week describes the process for such appeals. Export certificates from the FDA are critical for manufacturers’ ability to export US-approved devices to other countries and any delay could have serious commercial … Read more
In the last 2 weeks, the FDA has recalled 26 over-the-counter (OTC) eye drop products sold at major pharmacies such as CVS, Rite-Aid, Target, Walmart, and others, all apparently linked to one manufacturer. The eye drops are suspected to be contaminated and their use poses a risk of infection in the eyes that could result … Read more
A recent publication of a placebo-controlled clinical trial in China with a Traditional Chinese Medicine (TCM) product showed signification benefits in the management of Acute ST-segment elevation myocardial infarction (STEMI). However, what would be the likelihood of FDA acceptance of clinical data from such a study to support its approval as a conventional drug? 0 … Read more
With a wide-ranging and far-reaching Executive Order signed this week by President Biden, the administration is implementing several requirements from developers of products containing Artificial Intelligence (AI) technologies that would affect digital health products, somewhat. The order is primarily focused on the safety and privacy of the information used to train AI algorithms but also … Read more
