iwewlkws 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
FDA expects all manufacturing facilities, big and small, new and old, to be equally compliant to its GMP requirements, but it is often hard for the new manufacturers to prioritize the various areas of compliance to be meet FDA’s expectations. In a recent conference presentation, FDA’s leaders from the Office of Pharmaceutical Quality presented a … Read more
Online sale of illegal and/or low quality products, particularly those regulated by the FDA, is a major problem due to lax enforcement. But some websites are trusted more than others by consumers; Amazon is one of them. A product sold on Amazon is generally assumed by the consumers to be legally sold in the US, … Read more
Since 2016, FDA has been compiling a list of endpoints used in clinical trials used to support NDA applications for drugs. The list called the “Clinical Outcome Assessment (COA) Compendium” organizes all the endpoints used in clinical trials by disease area and product, and includes all endpoints used in NDA and Efficacy Supplements to NDAs. … Read more
