iwewlkws FDA has maintained officially that cannabidiol (CBD) is regulated as drug and hence it is illegal to add CBD to food and dietary supplement while at the same time letting thousands of CBD containing food and supplement products sells openly. CBD is the active ingredient of one FDA-approved drug, Epidiolex, but is available in thousands … Read more
FDA is not allowed by law to report submission of NDA and BLA applications or when it rejects these applications, but submitters do. In more than 97% of the times, companies announce via news releases, SEC filings or both, the submission of their market approval applications. A publication by FDA officials in JAMA this week … Read more
Over the last two decades Clinicaltrials.gov has become an invaluable archive of all clinical trials where one can easily register a clinical trial, few questions asked; and that’s the problem. It has also become home to dubious and illegal clinical trials. There are trials pretending to be credible by virtue of being listed on a … Read more
Traditionally FDA officials have avoided directly inserting the Agency in discussion on the ethics of high drug prices, till this week. This week, the FDA commissioner (acting) made an off-hand comment at a conference that seems to justify the $2.1 million price tag on a recently approved gene therapy from Novartis. He said that the … Read more
A year after the federal Right-To Try (RTT) Act became law, there have been only 2 reported cases where the law was used to provide treatments to patients. During the same time hundreds of compassionate use INDs were approved by the FDA. It is no secret that the RTT was designed to circumvent FDA review, … Read more
Americans throw away about 40% of purchase food every year for non-quality related reasons. Basically, food good enough for human consumption is wasted away due to inaccurate or misleading labeling practices in the food industry. This week FDA announced that it strongly recommends all food to contain the unambiguous label of “Best if Used By” … Read more
A report on the state of industry predicts that nine emerging technologies will transform the healthcare market to be more patient centric, efficient, and economical. While the predictions may seem obvious, the report does provide a comprehensive overview of the various technologies being developed that could be useful for program planners and thought leaders. Four … Read more
A survey of individuals with online access to their medical records showed that 3 out of 4 preferred to talk to their physicians over self-review of such information indicating a significant barrier to the use of mobile healthcare applications and real world data from medical records. Healthcare apps rely on the premise that users will … Read more
Over the last few years, the FDA and EMA has been working together to confirm that regulators in all European Union member countries can carry out GMP inspections at levels equivalent to the FDA. The goal is to recognize each other’s GMP inspections and avoid duplication of audits. EMA recognized FDA to be an equivalent … Read more
FDA annual report on the “State of Pharmaceutical Quality” shows that most the manufacturing sites audited by FDA have an average score of between 7-8 out of 10. Two-thirds of all drugs sold in the US are manufactured in the US, India and China with the US-based sites accounting for about 40%, those in India … Read more
