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
Last year when the federal Right to Try (RTT) Law was passed; it’s main purpose as to undermine FDA’s compassionate use program. A survey from GAO released this week shows the opposite. A year after becoming a federal law, the RTT is unpopular with manufacturers who prefer the FDA’s compassionate use program for providing investigational … Read more
Over the weekend, FDA issued a Warning Letter to Stemell, Inc., a manufacturer of umbilical cord blood stem cells for allogeneic use. The letter contains an element not seen in previous warning letters to stem cell companies that point towards FDA’s strategy for the upcoming enforcement actions on these companies. In the Warning Letter, FDA … Read more
Over the last 10 years, most clinical trials used to support approval of anti-cancer drugs lacked diversity in the trial population with only about 10% including reasonable participation by the four major races – whites, blacks, Hispanics, and Asians – and only about 25% conducting race subgroup analysis to evaluate demographic effect of treatment outcome. … Read more
