iwewlkws 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
Minorities represent a small fraction of subjects participating in clinical trials. A good way to improve minority participation in clinical trials could be through investigators from these communities. In an essay published this week, Dr Kyle Mack, a Chicago doctor, who is African-American describes how being from the community opens doors for him to get … Read more
It is hard to conduct placebo-controlled clinical trials, particularly in rare diseases. FDA released a new guidance document last week that provides ways to use historical controls to reduce and possibly eliminate placebo controls in all clinical trials. All diseases have a natural course under available standard of care which can be charted and used … Read more
FDA prefers that legacy clinical trial programs where a given product is tested through long clinical trials with generalized designs be replaced with modernized clinical development programs containing enrichment strategies, adaptive designs, master protocols, and operations supported by mobile technologies. Last week, FDA finalized two older guidance documents, one on enrichments strategies describing ways to … Read more
