The wireless communications sector is a heavily regulated industry area where regulatory authorities have remarkably much power in defining the market dynamics. It has been widely debated which amount of regulatory measures are necessary without having too much distorting effect on healthily working free markets. However, regulation is usually reasoned merely by economic arguments, overlooking ...

This document provides guidance to national regulatory authorities (NRAs) and vaccine manufacturers on the production and quality control of candidate live attenuated dengue virus vaccines by outlining the international regulatory expectations for product characterization. It should be read in conjunction with the WHO guidelines on nonclinical evaluation of vaccines (1), and the WHO guidelines ...

Biosimilar monoclonal antibodies are being developed globally for patients with different types of solid tumors and hematologic malignancies. Applications for proposed biosimilar monoclonal antibodies are being submitted to the regulatory authorities around the world and may increase patient access to key treatment options upon approval. An understanding among stakeholders (e.g., physicians, pa...

The increasingly used concept new public health indicates that a fundamental change has occurred in the goals and methods of disease prevention and health promotion. The change is often said to imply less expert-driven governing of citizens. In this article, governing technologies in the field of public health in Denmark and Sweden are analysed to investigate whether substantial changes have ta...

Conventional parameters such as frequency, level, or bandwidth are often insufficient for identifying a transmitter. This is especially true if several transmitters share a frequency, e. g. in amateur radio or in ISM bands. If you want to unambiguously recognize signals of data transmissions, you have to determine additional technical parameters and analyze the decoded contents of the emission....

The requirements for minimising microbial contamination in pharmaceutical cleanrooms are in regulatory documents published by authorities that include the European Commission1 and the Food and Drug Administration in the USA2. These authorities also suggest the use of risk management and assessment techniques to identify and control sources of microbial contamination3,4. The authors of this arti...

Under the predominant existing paradigm, in balancing the public interest in transmission line planning and siting decisions most state regulatory authorities weigh the benefits to the customers of a specific utility system, or to the consumers in an individual state, against potential adverse consequences. This approach to transmission siting was designed to serve the model of a vertically-int...

Colombia's discharge fee system for water effluents is often held up as a model of a well-functioning, economic incentive pollution control program in a developing country. Yet few objective evaluations of the program have appeared. Based on a variety of primary and secondary data, this paper finds that in its first 5 years, the program was beset by a number of serious problems including limite...

The Note for Guidance ICH S1B Testing for Carcinogenicity of Pharmaceuticals (CPMP/ICH/299/95) offers the option to use short or medium-term in vivo rodent test systems, such as transgenic and knockout animal models, in place of a second 2-year rodent bioassay. Ideally, such studies should supplement the long-term carcinogenicity study and provide additional information that is not readily avai...

Increased emphasis on routine screening of chemicals for potential neurotoxicity has resulted in the development of testing guidelines and standardized procedures. A multiphased, tiered-testing strategy has been proposed by numerous expert panels to evaluate large numbers of chemicals. In a regulatory context, however, a formal tiered-testing approach is not used, mostly because of the constrai...