Prashant Kumar

Last year FDA conducted 17,487 audits worldwide, and issued 5045 FDA 483s, meaning that about 30% of the audits lead to non-compliance in more than one regulated area. There were 498 Warning Letters issues during the same time showing that 1 in 10 audits found repeat violations that required more serious enforcement action by FDA. … Read more

FDA would like developers of new medical devices do fewer clinical trials, use clinical trial data from outside the US, rely on data from uncontrolled open-label studies, and use unconventional data to support PMA and 510k applications. Manufacturers should try to “use the minimum amount of information necessary to adequately address a regulatory question or … Read more

Over the last few years, FDA created the Early Feasibility Studies (EFS) program to encourage developers of new medical devices to conduct such studies in the US under IDEs instead of other countries. An EFS is a small clinical trial on an early prototype of a Class III medical device to evaluate the design concept, … Read more

Since its announcement of four new guidance documents regarding regenerative medicine about a month ago, there has been a lot of confusion in the regenerative medicine industry. Some of FDA’s actions appear as if the Agency has decided to ignore most public comments it received in the recent years on the topic, indicating that FDA … Read more

This week FDA described its heavily hands-on approach for the approval of “Artificial Pancreas” to highlight how FDA reviewers could play an active role in approval of innovative new products. There are several lessons for other developers in this story and notes of caution as well. The automated insulin dosing system, commonly known as an … Read more

Dietary supplements are frequently found to have major quality issues so this should not come as a surprise that another formal study found that about half the products did not contain the active ingredient on the label, about 40% contained other unapproved drugs, about 1 in four products contained products not listed on the label … Read more

The week before Thanksgiving, FDA announced “a comprehensive regenerative medicine policy framework” with great fanfare and it appeared that it is finally going to make significant changes to its policies for regulating stem cells. But a review of this framework shows that it is mostly a rehash of old statements and policies. Four new Guidance … Read more

In the 21st Century Cures Act, FDA is required to accept Real World Evidence (RWE) in support of market approval decisions. However, the RWE is based off the Real World Data (RWD) which is highly variable and hence could impact the acceptability of RWE derived from such RWD. One of the most sought-after RWD is … Read more

Last week FDA announced initiatives that would reduce the direct regulation of most general health genetic tests citing low risk of such tests. A new study published this week raises concerns about incorrect genetic tests of this kind citing specific clinical outcomes linked to the false results. General Health Risk (GHR) tests are designed to … Read more

The recent movie, Passengers, showed a machine that could diagnose diseases, prescribe medications, and perform several complex medical procedures, all without the intervention of a human doctor. It seems real life may be catching up to science fiction sooner than we may think. Over the last year, FDA has slowly eliminated or toned down several … Read more