iwewlkws 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
FDA’s decisions about the products it reviews can be mind-bogglingly subjective. When two products, for the same indication, with almost identical clinical development plans, and developed by the same company, have extremely contrasting FDA review outcomes it makes it impossible for the public to know the true reasons for such diverse decisions. Three year ago, … Read more
Last couple of weeks would have been a nightmare for a crisis manager working for Novartis. The company has been accused of fraud by FDA and threatened with fines and other punitive actions, investigated by the US Congress, subject to public ridicule, and apparently deceived by its acquisition target. In all that, one cannot forget … Read more
FDA drug establishment database is filled with tens of thousands of outdated entries for drugs that are no longer being marketed. In 30 days, FDA will remove all such listings to assure that the drugs establishment list contains only those that are current. The drug established database is critical for FDA’s regulation of the drug … Read more
The general quality expectations for clinical trials are described in a new ICH guidance adopted by the FDA this week. The concept of Quality-by-Design (QbD) has been the gold standard for defining quality expectations in manufacturing operations but similar standards lack for the conduct of clinical trials. It is generally accepted that the quality of … Read more
