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It is critical that a product be properly classified as a drug or medical device. For products where a clear unambiguous scientifically justifiable classification as a drug or medical device cannot be made, the developer are required to make a Request for Designation (RFD) with the Office of Combination Products (OCP) at the FDA. Classification of a given product … Read more

This week, the Indian regulators announced reversal of a rule from 2 years ago that restricted an investigator from participating in more than 3 clinical trials at a given time. This is a very minor change that has little practical impact on the status of clinical trials in India. The clinical trial industry in India has been … Read more

Not really, but we might be going down the road to create one with NIH funding. This week, NIH lifted a moratorium on insertion of human stem cells into early stage embryos of non-human vertebrate animals to create human-animal chimera. This represents a unique balance of scientific curiosity, medical benefit, and ethical dilemma. Human-animal chimeras have dominated … Read more

For many drugs, the mechanism of action is either unknown or not confirmed. In an assay published in The Scientist, three case studies were used to emphasize why it is not critical, if not required, to know the mechanism of action of a given drug. Three drugs used as case studies were the CNS drug lithium, … Read more

This week Philips Healthcare announced release of a smart watch very similar in functionality and appearance to Fitbit, Apple’s iWatch or Samsung Gear watch. However, the Philips watch has one difference from its competition; it is registered with the FDA as a medical device. Smart watches are not considered medical devices by FDA and do not require registration or … Read more

An email leak from a Democratic National Committee (DNC) led to the Chair of the DNC losing her job and the leader of the party barely surviving a major crisis on the eve of the convention. This followed concerns of security of personal and official emails. This episode highlights once again the high-risk of electronic … Read more

Negative audit findings make headlines every time a site in India is found to be in violation of GMP requirements by US FDA. For the last few years, negative news about drug manufacturing facilities in India dominated public discourse so much that it has become a cliché to use findings at sites in India for … Read more

Biologics manufacturing facilities using traditional stainless-steel bioreactors have to deal with significant manufacturing suite unavailability between production cycles due to expensive cleaning technology, extensive cleaning validation, and the associated loss of productivity and revenue. The use of single-use and disposal technologies such as single-use bioreactors (SUB) can greatly increase the production efficiency by reducing the … Read more

A review of the payments to physicians posted on the CMS Open Payment website indicates that there has been no decrease in the payments to physicians by companies. In 2015, drug companies paid $7.52 billion just like the $7.49 billion paid last year to more than 600,000 physicians of almost all kinds of specializations. The list of … Read more

Last year, during the drug pricing debate triggered by Turing Pharma’s Martin Shkreli, a San Diego compounding pharmacy Imprimis Pharmaceuticals announced that it would offer a cheap compounded version of the expensive FDA-approved drug. At that time, we criticized Imprimis based on our belief that such a practice will jeopardize all approved drugs. This week FDA confirmed … Read more