Clinical trials are complicated long-term and high-risk projects. But is it because of the inherent nature of the project, the regulations, the investigators, or the contractors hired to help with doing clinical trials? A recent opinion piece by two prolific clinical investigators blames the CROs with adding many unnecessary and overtly cumbersome processes that make … Read more
This Monday FDA released its new redesigned website. The content has been reorganized, with new colors, images and other improvements, but the changes will require reacquainting one with the website. Many bookmarks have been transferred to the new website, but many old bookmarks don’t work. The key pages have been made less wordy with hyperlinks … Read more
The USDA recently enacted an internal policy that all peer reviewed publications authored by its scientists carry a disclaimer that it represents “preliminary” findings. While this policy seems to be limited to USDA only, but it was not publicized and there is no way to know if similar policies exist at other government agencies such … Read more
Last week FDA approved a unique device for the treatment of ADHD in 7-12-year-old children. The process followed for the approval of this first-of-its-kind device highlights the lengths to which FDA may go to approve new devices with unique technologies that can be a useful lesson to other developers of products that meet similar conditions. … Read more
One of the reasons patients participate in clinical trials, particularly pivotal (Phase 3) trials, is to get access to new medication not yet approved. For many patients, particularly with life-threatening diseases who have exhausted all available therapies, a clinical trial may offer the only option available for potential benefit. And many times, it works. The … Read more
Earlier this year, FDA had announced that it would publish a list of unlawful ingredients in dietary supplements, and this week it did. FDA’s list contains four ingredients. The list appears pretty underwhelming particularly because it was highlighted with an accompanying blog by FDA’s Deputy Commissioner for Food Policy. It is hard to imagine that … Read more
FDA needs to complete its assessment of foreign inspections program for drugs and food, something that was originally recommended in 2016. Specifically, GOA requested, and FDA agreed to evaluate the effectiveness of its foreign offices with regards to drug safety-related outcomes, such as inspections, import alerts, and warning letters. FDA told GAO that since 2016 … Read more
A “strange” news release by Zogenix announced that it received a Refuse-to-File (RTF) for its NDA for Fintepla, a breakthrough therapy designated (BTD) drug for epilepsy. There are many clues in this announcement that could be lessons for others. The strangeness of the news is in the details of the RTF issues: missing chronic non-clinical … Read more
This week FDA reiterated its goal to enforce strict regulation of all stem cells treatment. In the strongly worded blog, FDA emphasized that autologous stem cell treatments are also regulated under the regulations for INDs and BLA and that it is false to claim that FDA jurisdiction over such treatments is not applicable. FDA also … Read more
A joint blog by the FDA Commissioner and the Center Directors for Drug and Biologics this week highlighted the important role expanded access (also known as Compassionate INDs) plays in the treatment of patients with no available options, and the benefits it may provide the manufacturers. Besides being potentially helpful to needy patients, FDA noted … Read more
