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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

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