The FDA has been rolling forward with the implementation of the new medical device rules whereby the Lab Developed diagnostic Tests (LDTs) will be converted to conventional In Vitro Diagnostic (IVD) devices or removed from the market. It is the responsibility of the manufacturers of LDTs to navigate the new regulatory environment. A new page … Read more
Electronic medical records and other electronic systems are ubiquitous sources of the source data for clinical trials. There is confusion and misinformation about the FDA requirements from such data particularly in pragmatic trials where the clinics participating in the clinical trial also provide health care services. FDA’s new guidance on the topics answers many common … Read more
The submission and tracking portal maintained by the Center for Devices (CDRH) at the FDA is an enhanced tool for not only the electronic submission of almost all device applications but also for tracking the progress of the review and interacting with the FDA reviewers. This week, the FDA added more functions to it. The … Read more
Peer-reviewed publications are the currency of scientific research, the number of publications being directly correlated to the credibility of the research being discussed. But there also have been reports of rampant manipulation and misrepresentation of data in scientific publications. So, how much can one rely on published literature in support of the clinical potential of … Read more
Clinical trials are run at clinics with patients, that’s how it has been for the last. So, the new FDA guidance on how to run trials at clinics may come as a surprise to many doing such trials for the last few decades. Doctors act as investigators and patients become subjects at the same location. … Read more
Clinical trials have become increasingly globalized over the last three decades with sponsors routinely conducting multinational clinical trials to evaluate new drugs. A new guidance document from the FDA seems to indicate that the FDA would like to buck that trend. The guidance document lists several previous requirements with a new tone that seems to … Read more
Remote or decentralized clinical trials can make the lives of all stakeholders simpler while yielding high-quality data. Most clinical trials these days involve hybrid systems where parts of the traditional clinical trial activities are conducted remotely. The sponsors must understand the FDA’s expectations from such trials. A new FDA Guidance Document released this week helps … Read more
Veterinarians are responsible for ensuring the safe use of prescription drugs for animals. Federal law requires that prescription animal drugs can only be prescribed or dispensed by a licensed veterinarian, not by veterinary technicians or other staff. This is because these prescription animal drugs may have harmful effects if used incorrectly or without proper guidance. … Read more
Many drugs are approved with a boxed warning (BW) on their labels assuming that the prescribers and patients would make informed decisions about using these drugs. But how effective are they in this purpose? An FDA study to evaluate BW in prescription practices yielded interesting but unsurprising findings. A BW highlights serious risks associated with … Read more
De Novo classification requests require a significant investment of time and resources. Many applicants are new to the FDA regulatory processes and need help in putting together a reasonable request. In the last few years, the FDA has tried to help medical device submitters with application formatting via its eSTAR templates. This month they expanded … Read more
