iwewlkws Drug and biologics intended to treat rare diseases require better planning and due diligence due to unique challenges posed by smaller target populations. In a new guidance document released this week, FDA lists several common sense measures for sponsors prior to conducting the first-in-human studies with such products and suggests that these be discussed at … Read more
A review of doctor’s habits for relying on diagnostic tests without fully understanding them shows that doctors increasing use results of diagnostic tests incorrectly. Diagnostic tests are over-prescribed and highly trusted, without appreciating the probabilistic nature of diagnostic tests. If well-trained professionals can be misled by the results of the diagnostic tests, one can argue … Read more
In industry-funded clinical trials run by academics, the industry participants play an important role in the design, conduct and reporting of the trials, a fact appreciated by more than 90% of the academic collaborators. In a survey published last week, researchers reviewed critical decision processes regarding Phase III and IV clinical trials lead by academic … Read more
The list of planned Guidance Documents is a good indicator of FDA’s priorities for the coming year. Each year each center at the FDA publishes the list of Guidance Documents it plans to publish or draft next year. CDRH’s list of Guidance Documents shows that software-based products are the top priority of the Center this … Read more
Traditionally, when making changes, updates or improvements to Class II devices approved under the 510k process, the developers had to file a new traditional 510k for the updated device. Under a pilot program launched earlier this week, FDA expanded the special 510 process to include most modifications of previously approved 510k devices. The special 510k … Read more
There has been a lot of criticism over the years of both FDA and NIH for not enforcing the laws for reporting clinical trial results on clinicaltrials.gov. Last week FDA announced a process for penalizing companies and individuals under the same law. It has been more than 10 years since the Food and Drug Administration … Read more
Over the last few years, FDA is increasingly refusing to meet companies, either in-person or via phone, and instead providing written responses to the applicant’s questions, a process called “Written Response Only (WRO)”. The WRO process which was originally created to make it easier to answer routine questions in certain meeting requests is now being … Read more
FDA has declared sort-of an all-out war on e-cigarettes citing increased use by adolescents and young adults with hundreds of Warning Letters and threats of punitive actions. There is no argument that children should not be smoking but by expanding the definition of smoking to include inhaling essentially water vapor mixed with pure nicotine, it … Read more
This week FDA released an educational guidance for prescribers of opioid drugs intended to limit opioid prescription through increased diligence by the physicians. The FDA guidance is very similar to that from CDC released last year for the same purpose. Most of the patients get opioid drugs via prescriptions from their physicians, hence the best … Read more
In a detailed report of the current practices for application review by FDA, the Office of Inspector General (OIG), Department of Health and Human Services, recommended FDA take additional steps to assure that medical devices are protected from cybersecurity issues. These include having sponsors discuss cybersecurity issues at pre-submission meetings, adding cybersecurity assessment in the … Read more
