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The US Food and Drug Administration (FDA) has directed considerable effort towards modernizing its regulatory processes over the past decade to address the challenges in the drug development sector. Through partnerships and input from stakeholders, multiple initiatives are under way, many projects have been launched, several have resulted in tangible results, and many are ongoing and under discussion. We are learning that collaborative efforts can better inform and leverage existing knowledge, that the challenges of data sharing and intellectual property can be overcome, and that there is wide interest in partnering to address key public health regulatory science issues. It is crucial that we continue to build on these initial efforts to facilitate drug development. [ABSTRACT FROM AUTHOR]

Since 2004, the Critical Path Initiative has prompted industry, academia, and government agencies to work together to share the information, technology, and expertise critical to modernize and transform our approach to drug development and review. Various collaborations have been sharing data in a precompetitive space, establishing data standards, and facilitating collective tool development. As a result, the organization is making progress toward developing knowledge and tools that can reduce uncertainty in medical product development. [ABSTRACT FROM AUTHOR]

BACKGROUND: This study investigated differences in weight loss outcomes in obese women with Type 2 diabetes (T2D) compared to those without T2D attending a 6-month dietetic led 'Lifestyle' intervention. In those who had failed to reach weight loss goals using the 'Lifestyle' approach, the study further examined the effect on weight loss with the addition of sibutramine (Reductil, Abbott Laboratories, USA) over a 6-month period. METHODS: The study comprised a case-control analysis of data from 38 obese female patients (18 with T2D) from the 'Lifestyle' and 'Pharmacotherapy' clinics attending a tertiary hospital in the UK. RESULTS: In the 'Lifestyle' treatment groups, those with T2D lost significantly less body weight than those without T2D [5.26 kg (4.54%) versus 9.89 kg (9.55%), respectively]. For subjects who had failed to lose weight via the 'Lifestyle' intervention, the addition of sibutramine resulted in a similar weight loss compared to their pair-matched 'Lifestyle' only 'successful' counterparts (9.66% versus 9.55%). CONCLUSIONS: Not all obese women, and those with T2D in particular, will derive benefit from 'Lifestyle' advice and those who are resistant to this treatment approach may be assisted by pharmacotherapy. Dietitians can play a role in identifying those individuals who may benefit from the use of pharmacotherapy. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "The impact of supportive counselling on women's psychological wellbeing after miscarriage-a randomised controlled trial," by G. W. S. Kong, T. K. H. Chung, and I. H. Lok in the 2014 issue.