This article is a review of the use of quantitative (and qualitative) structure-activity relationships (QSARs and SARs) by regulatory agencies and authorities to predict acute toxicity, mutagenicity, carcinogenicity, and other health effects. A number of SAR and QSAR applications, by regulatory agencies and authorities, are reviewed. These include the use of simple QSAR analyses, as well as the...

This document provides a comprehensive review of information and data relevant to the environmental risk assessment of the protein 5-enolpyruvylshikimate-3-phosphate synthase isolated from Agrobacterium sp. strain CP4 (CP4 EPSPS) and presents a summary statement about the environmental safety of this protein. All sources of information reviewed herein were publically available and included: dos...

Vaccine developers are required to submit a clinical trial application to the authorities in each country where a clinical trial will be conducted. The application has to be made both to the relevant Ethics Committees and to the National Regulatory Authorities, and only after appropriate clearance by both can a clinical trial commence. This paper describes two specific strategies, joint reviews...

Nanotechnology is widely used in many aspects of the design and manufacture of medical devices. To date, many of these new medical devices, referred to as nano medical devices, have been submitted to health authorities for premarket regulatory review. There are ongoing discussions between medical device manufacturers and regulatory authorities regarding the standards and methods required for th...

Why do regulatory authorities scrutinise mergers and acquisitions? The authorities themselves claim to be combating monopoly power and protecting consumers. But the last two decades of empirical research has found little supporting evidence for such motives. An alternative is that M&A regulation is actually designed to protect privileged firms. We provide a test of protectionism by studying whe...