European Union law prohibits companies from marketing drugs off-label. In the United Kingdom—as in some other European countries, but unlike the United States—industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2) shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion.

I have posed 50 questions each to the founders of 50 young Indian biomedical firms that are less than 5 years old. The questions were on the following themes: the backgrounds of the founders and their employees, the area of work of the company, its location and incubation experience, its funding and expenditure, its IP and licensing, its clients, and its risks and challenges. Several are doing pioneering work and the overall picture is impressive. The country should become a source of appropriate, high quality and affordable biomedical products and services in a few year.

As vaccine manufacturers tackle increasingly intractable pathogens, vaccines will be developed that show efficacy, but that are less efficacious than established vaccines. Consequently, regulatory and public health authorities will be faced with difficult decisions about whether such vaccines should be recommended for implementation and, if so, under what circumstances. The RTS,S/AS01 malaria candidate vaccine provides an important example of such a challenge.