iwewlkws It has become an annual ritual for FDA to release several new Guidance Documents in the last few days of a year and true to that, the FDA did exactly that by releasing 21 new Guidance Documents in the last 13 days of December. Many of these Guidance Documents affect critical aspects of FDA regulated … Read more
There were many developments at the FDA last year such as the approval of multiple cell and gene therapy products, the first CRISPR product approval, the formal end of the pandemic, the rise of remote inspections, and the retirement of the legendary Janet Woodcock. However, the one action by the FDA that would likely have … Read more
Last year was unquestionably the Year of ChatGPT. It affected all aspects of life, including healthcare and FDA-regulated products. ChatGPT did for artificial intelligence (AI), what iPhones did for smartphones 15 years ago. Although several AI-based medical products have been used in medicine and even approved by the FDA in the last few years, no … Read more
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
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
