Bernie Sanders famously said that “people are sick of hearing about Hillary Clinton’s “damn emails”, and perhaps he was right. However, the findings from the FBI investigation of the matter continue to highlight several issues with email security common with many senior executives. Part 11 regulations provide some of the best policies for system integrity and data storage that … Read more
A common question asked when choosing a suitable contract research organization (CRO) is if one should go with a big CRO or a small CRO. There are 751 CROs in the World with about half of them or 332 in the US. Of these, the top 10 CROs account for about 57% of the total revenue in the … Read more
This week FDA announced a major modernization of the GLP rules primarily aimed at adding detailed quality system requirements such as requiring that GLP facilities maintain detailed SOPs on the responsibilities of management, period assessment of the quality system, and electronic documentation. Per the new rules the management of a given facility will be held responsible for … Read more
Our pets share not just our homes and hearts but also our life style and diseases. In many ways our dogs and cats are much closer representatives of humans than any test animal. So, can drugs be tested in a clinical trial in our pets to find out the ones that hold more promise in … Read more
This week FDA announced the final rule for determining the “Generally Recognized as Safe” (GRAS) status of food ingredients. The new process replaces the current process of petitioning FDA to affirm the GRAS status, with a voluntary notification about a conclusion that a substance is GRAS under the conditions of its intended use in human food or … Read more
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
