In its ongoing reorganization efforts to align the review and oversight activities with the changing landscape of the products it regulates, FDA announced a major reorganization of its oncology product review divisions by renaming the main office to Office of Oncologic Diseases (ODD) and creating 6 new divisions within the office each focused on fewer … Read more
Health algorithms used to manage health decisions could lead to erroneous outcomes if data used to build and or train them is biased. This is particularly a concern since most health algorithms do not require a formal FDA approval particularly if they are labelled as MDDS products. A recent report demonstrated how a widely used … Read more
A joint government task force lead by FDA to study the causes of drug shortages found that these shortages occur primarily because the manufacturers are unable to charge higher prices for their drugs even when there is a shortage and that it takes a longer than anticipated time to catch-up once a drug is in … Read more
For the last several years, questions have been raised in public about the quality of drugs imported into the US from India and China, mostly based on FDA audit findings and Warning Letters. At the same time FDA has repeatedly insisted that its system for review and inspections is adequate to protect the US drug … Read more
This week FDA and FTC jointly issued a Warning Letter to another CBD manufacturer for selling CBD as an unapproved drug for pediatric diseases among other claims, and for selling CBD as a dietary supplement. This warning letter is similar to other warning letters issued by FDA in recent years to manufacturers of CBD containing … Read more
Healthcare management apps pose several risks to consumers using them including giving incomplete or incorrect information, providing non-validated instructions for managing a given health condition, failure to respond to health danger, and faulty alarms. This is based on a review of 74 independent clinical studies conducted in the last two years to evaluate the safety … Read more
Only 15% of clinical trial data could be replicated using real world data (RWD) from electronic health records and insurance claims databases by researchers trying to evaluate if RWD could replicate clinical trial evidence and potentially replace clinical trials. The report highlighted well known limitations of patient records, but also offered clues to what could … Read more
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
