In vitro diagnostic devices (IVDs) help clinicians determine specific conditions, monitor therapeutic efficacy, and prevent drug resistance development. While stringent regulatory authorities (SRAs) regulate IVDs in most high-income countries, regulatory authorities in many low- and middle-income countries (LMICs) are nonexistent or do not enforce rigorous standards. In 2010, the World Health O...

Perhaps the single biggest distortion to the free enterprise system is when a number of private institutions are deemed by political and regulatory authorities as too systemic to fail. Resources are trapped in corporate structures that have repeatedly proven their incompetence, and further resources are sucked in from the taxpayer as these institutions destroy value. Indeed, these institutions ...

DRUG REGULATION SERVES TO PROTECT PUBLIC HEALTH. DONE RIGHT, IT DRIVES THE ongoing assessment of product safety, efficacy, and quality and promotes the development and availability of new and better products. However, in our modern world, the mosaic of regulations that govern drug development and oversight nation by nation are creating unnecessary barriers to the efficient delivery of safe, inn...

Regulatory authorities and scientific programs within the World Health Organization (WHO) have consistently concluded that glyphosate is not carcinogenic. The International Agency for Research on Cancer’s (IARC) classification of glyphosate as a Group 2A, “probable human carcinogen”, is inconsistent with the conclusions reached by other WHO expert committees and with decades of reviews by regul...

Drastic regulatory changes in Japan since 1997 have had a considerable impact on the way new medicines are developed. The regulatory authority itself has been transformed. Clinical trials are now performed according to international guidelines. Clinical data generated in one area are acceptable in the rest of the world in some cases through a bridging process that is viewed as only temporary. T...

This article reviews the off-label recommendations and use of vaccines, and focuses on the differences between the labelled instructions on how to use the vaccine as approved by the regulatory authorities (or "label"1), and the recommendations for use issued by public health advisory bodies at national and international levels. Differences between public health recommendations and the product l...