iwewlkws 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
FDA is responsible to monitor and warn consumers about food borne infections to prevent illnesses, but it could take weeks and even months between when FDA becomes aware of a contaminated food and when the recall process begins. And during that time unsuspecting consumers could keep buying the tainted food and get sick. In an … Read more
Last week, the Center for Biologics (CBER) announced a new kind of meeting with the FDA reviewers aimed at exploratory discussions prior to initiating significant development work. These meetings are expected to primarily provide an opportunity to discuss the preclinical studies and manufacturing issues related to first-in-human trials with new biological products. These meetings seem very … Read more
The informed consent for any clinical trial requires the sponsor to inform the potential participants about available treatment options outside the trial. For life-threatening indications, it would mean telling the patients that they could get the same investigational drug via the Right-to-Try law without participating in the trial, thereby eliminating the very reason these patients … Read more
FDA charges fees for most market approval applications but grants waivers to a lot of applicants based on various criteria. A new Guidance document released this week, discusses all the various ways the fees can be reduced or waived by the FDA. In case the applicant has already paid the fee, the fee can be … Read more
In two new Guidance documents released this week, FDA presents a detailed explanation of its requirements for advertisement of approved products. In a slight policy shift, FDA walks away from the rigid enforcement of approved labels and provides some flexibility in marketing communications, while maintaining its control over new uses of approved products. The Guidance … Read more
In a stern letter to Tiger Medical of New Jersey, FDA directed the company to stop selling its HIV diagnostic test online. Tiger medical got approval for its Alere Determine™ HIV-1/2 Ag/Ab Combo test kits in 2013 and had been marketing the test online on its website. It was obvious that anyone could purchase the … Read more
