The ongoing fi nancial crisis has revealed a number of weaknesses and gaps in fi nancial supervision. Following a number of reports at both the international and national levels, regulatory authorities are pursuing an ambitious agenda aimed at remedying the weaknesses identifi ed: a number of EU Member States are implementing or planning reforms of their national institutional frameworks, which...

A new European guideline on drug-eluting stents (DES) introduces for the first time detailed information that European drug authorities should review concerning the medicinal substance that is incorporated into this type of drug-device combination product. Part I of this article discussed European requirements that apply to DES. This article discusses the new guideline, other stent guidelines, ...

This article contains a broad overview of the history of Federal regulation of nursing homes from the perspective of an individual involved directly for a number of years in the development and enforcement of Federal regulatory requirements. The article also contains a summary of the major statutory changes in the Omnibus Budget Reconciliation Act of 1987 that affect nursing homes. Finally, the...

The yet-unrealized potential for more "personalized" Direct-to-Consumer (DTC) tests to fundamentally alter the practice and economics of healthcare is undeniable. However, there are also many challenges to be met, including the herculean task of ensuring that the information provided by such tests is scientifically sound and, ideally, medically actionable. We consider recent events in DTC testi...

A significant amount of information is already available through government and non-government programs. Given this, the emphasis of this environmental monitoring report has been on collating data from existing programs of sampling and analysis. It collates existing published data, or unpublished data that have been obtained directly from regulatory authorities. The report attempts to identify ...

Preservatives such as benzoic acid and parabens are being tested on a regular basis by regulatory authorities and food testing laboratories as they are widely found in condiments and beverages such as fruit juices, sports drinks and soft drinks. The consumption of excessive amount of preservatives can lead to adverse health effects such as allergy. Also, the levels of these preservatives in foo...

A new European guideline on drug-eluting stents (DES) introduces for the first time detailed information that European drug authorities should review concerning the medicinal substance that is incorporated into this type of drug-device combination product. Part I of this article discusses European requirements that apply to DES. Part II will discuss the new guideline, other stent guidelines and...

Genetic research into the select agents Burkholderia pseudomallei and B. mallei is currently hampered by a paucity of approved antimicrobial drug-selection markers. The strict regulations imposed on researchers in the United States but not in other parts of the world lead to discrepancies in practice, hinder distribution of genetically modified strains, and impede progress in the field. Deliber...

Monitoring the quality of instrumentation used in nuclear medicine is mandatory to guarantee the clinical efficacy of medical practice. A national program for the quality control of nuclear medicine instruments was established in Cuba and was certified and approved by the regulatory authorities. The program, which establishes official regulations and audit services, sets up educational activiti...

What is the best strategy to approve novel drugs for disease such as sleeping sickness that predominantly affect patients in Africa? How can African regulators best be supported to evaluate these drugs for their own populations? For many years, African medicines regulatory authorities (MRAs) have relied on stringent regulators in developed countries to assess novel pharmaceutical products such ...