iwewlkws

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

It has been a common assumption that one must conduct two or more pivotal clinical trials to support the NDA or BLA for a new drug or biologic. But it is not true. About a third of NDA and BLA applications for new products approved by FDA in 2018 were based on one clinical trial … Read more

A very short 4-page Guidance Document from FDA Guidance Document gives little, if any. It defines Real World Data (RWD) and Real World Evidence (RWE), and states that both RWE/RWD can be used to support INDs and NDAs. It also provides some examples of such use, along with checklist for the cover letter of a … Read more

This week FDA released a “new” guidance about medical device meetings which is rehash of old advice with several tips to make these meetings productive. It can be argued that there are few, in any, new proposals in this guidance but it is still a useful read for the industry. FDA meetings are an excellent … Read more

Clinical trials are complicated long-term and high-risk projects. But is it because of the inherent nature of the project, the regulations, the investigators, or the contractors hired to help with doing clinical trials? A recent opinion piece by two prolific clinical investigators blames the CROs with adding many unnecessary and overtly cumbersome processes that make … Read more