iwewlkws The enrollment criteria for most clinical trials exclude older or pediatric patients, patients with organ disfunctions, pregnant and lactating women, and patients with multiple chronic conditions. An FDA report released this week summarizes how data from such patient populations can be collected to support inclusion of these populations on the product labels. Sponsors are reluctant … Read more
This week FDA approved the first mobile contraceptive app created by a Swedish startup. The app basically uses a calendar connected to temperature reading submitted by the users to calculate their menstrual cycle and predict more fertile days than others. There are several reasons why this approval may be both a gimmick and a significant … Read more
A report released last month by the Clinical Trial Transformation Initiative (CTTI), a joint venture of FDA and the Duke University, contends that all clinical trials should use mobile technologies to increase patient participation and retention, while reducing cost, increasing efficiency, and capturing real-time and real-world clinical data. The report acknowledges that the sponsors will … Read more
FDA announced last week that it is planning to create restrictions on using the word “milk” to describe non-dairy products such as almond milk, soy milk, etc. citing that consumers are “hurt” when non-dairy products are called “Milk”. It is hard to argue over the frivolity of this FDA initiative. Non-dairy products that look and … Read more
Recently the FDA Commissioner, who is a prolific Tweeter, started Sunday-special tweets called the “Sundaytweetorials” to discuss broad issues. Last Sunday’s “tweetorial” included a series of 22 tweets discussing issues related to clinical trial design. The tweets discussed common strategic considerations for clinical trial design and related issues. Although there were no new announcements or … Read more
This week FDA released a list of all surrogate endpoints used for approval of drugs and created a special meeting specifically to discuss creation of new surrogate endpoints. The list of surrogate endpoints includes more than 100 drug and biologic products approved by FDA over the last 10-15 years and cover practically all major indications. … Read more
Electronic health records (EHRs) provide a rich source of real-world health-related information which can be used as an electronic source data in clinical investigations. However, there are several conditions that one needs to meet before it would be acceptable to FDA. FDA has allowed use of electronic sources data (e-Source) for several years; the FDA … Read more
In a review of 46 drugs approved under the breakthrough therapy (BTD) program, it was found, not surprisingly, that most of the approvals were based on smaller, uncontrolled clinical trials, implying that the BTD programs leads to approval of unsafe drugs. However, this analysis ignores the core premise of this program, namely faster approval for … Read more
Serving on the FDA Advisory Committees is a considered a very prestigious accomplishment for most academic and professional experts who help FDA make tough decisions about new drugs. A survey of the post-Advisory Committee life of these experts found that for many, this also serves as an attractive credential for companies seeking to hire expert … Read more
About 40% of FDA’s senior leadership will be eligible to retire next year and about 15% of its overall workforce of 17,000 employees could also be eligible to retire. And that has FDA very worried about replenishing the talent. In an effort to hire more aggressively not only to prepare for the possible large-scale loss … Read more
