Negative FDA audits could have catastrophic consequences for the companies at the receiving end. It could lead to drastic financial losses, loss of credibility and even push the defaulter out of business. If a company is destroyed by a negative FDA audit, can it sue FDA for damages? Can a company successfully claim that the … Read more
In his response to a GAO report that FDA needs to evaluate appropriate implementation of the least burdensome requirements of the 21st Century Cures Act, the FDA Commissioner announced that FDA has already trained more than 90 percent of its reviewers in CDRH in least burdensome requirements for new medical device approval decisions, and that … Read more
FDA is working on new rules to require a simplified one-page Medication Guide for prescription drugs to supplement the longer package inserts that usually accompany a drug to make it easier for the patients to understand their medication. Earlier this week FDA announced its major policy goals for this year and it contains several things … Read more
FDA released a new guidance to describe the current process for arranging meetings with the review divisions in CDER ad CBER combining and simplifying information from previous guidance documents, updating some critical timelines and retiring the old defunct guidance documents on the same topic. In the last decade, FDA’s management carried out a major publicity … Read more
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
