iwewlkws A one-patient clinical trial could lead to a heartwarming story but requires incredible motivation and endless resources, and presents formidable regulatory, scientific and practical challenges for use beyond that one patient as is highlighted by such a trial reported this week. Doctors at Harvard Medical School, Boston Children’s Hospital with numerous partners announced a one-patient … Read more
Over the last seven years, FDA has initiated numerous programs to increase patient perspective in the development of new drugs that they may need. Starting with the Patient-Focused Drug Development (PFDD) meetings that started in 2012, FDA has increased the weight of patient perspective in regulatory decisions. However, sponsors need instructions on how to interact … Read more
Several expedited programs for market approval created in the last decade has led to products approved in much shorter time and with seemingly lesser burden of proof leading to critics accusing FDA of lowering its standards of approval and allowing riskier drugs to be used on patients. A blog by FDA leaders of the centers … Read more
Genetic tests such as those conducted by “23 and Me” reveal some of the most intimate health-related information about a consumer. And now 23 and Me has decided to use this information to pitch clinical trials to its consumers which should worry any privacy conscious consumer. 23 and Me is the biggest provider of direct … Read more
For the last two years, FDA’s Center for Drugs (CDER) is being reorganized to address the complexity of the products it regulates. These reorganization, termed “modernization”, has been presented by FDA as internal changes that will not affect ongoing and upcoming reviews of applications but there are several practical and logistical aspects of the move … Read more
A study published in the British medical journal Lancet this week reported that Artificial Intelligence (AI) algorithms can read and analyze diagnostic imaging data at the same sensitivity and specificity as human professionals. Although the research was limited by the lack of studies directly comparing AI algorithms to human professionals, and the data used was … Read more
This week Novartis blamed the “stonewalling” of its internal probe into data manipulation by two of its former employees for the delay in informing FDA of the same. Accusing ex-employees (or even current employees) is not a new tactic by a company at the center of a regulatory crisis but will it work for Novartis? … Read more
In the last 25 years, cancer related deaths have reduced by 27%, there are more new drugs to treat cancer approved by the FDA than any other disease, there are well known ways to prevent 2 out of 5 cancers, and strides have been made in the diagnosis of cancer much earlier than previously possible … Read more
For the last two years, American scientists of Chinese descent have been the target of intense Federal investigations of their research and information sharing activities, with little tangible protest from the scientific community at large. The nationwide investigations have been done in the name of national security which implies defense related research but has expanded … Read more
This week Apple created another big news with its announcement for the start of three clinical trials for three different indications using iWatch creating big anticipation for its forays into healthcare. The three studies use three different applications of iWatch for health-related uses. All studies are designed as open-label observational studies conducted in collaboration with … Read more
