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The development and approval of brincidofovir for the treatment of smallpox, a disease that was eradicated from the world over 40 years ago, has resulted in the second antiviral approved via the Medical Countermeasure Initiative (MCMi) to combat this disease. Approval of brincidofovir required a unique regulatory approach based on the FDA Animal Rule, and development was supported by many years of research and collaboration among academic investigators, the pharmaceutical industry and multiple government agencies. This article summarizes the FDA regulatory pathway and describes the challenges involved., (Published by Elsevier B.V.)

Objective: To report on demographic and tobacco product use correlates of tobacco product initiation (cigarettes, electronic nicotine delivery systems (ENDS), cigars, hookah and smokeless tobacco) among the US population., Design: Data were from the first three waves (2013-2016) of the Population Assessment of Tobacco and Health Study, a nationally representative, longitudinal cohort study of US youth (aged 12-17 years) and adults (aged 18+ years). Never users of at least one type of tobacco product at Wave 1 (W1, 2013/14) or Wave 2 (W2, 2014/15) were included (n=12 987 youth; n=25 116 adults). Generalised estimating equations were used to evaluate the association between demographic and tobacco product use characteristics at baseline, and tobacco product initiation at follow-up (ever, past 30 day (P30D), frequent (use on 20 or more of thepast 30 days)) over two 1-year periods (W1-W2 and W2-Wave 3)., Results: Youth aged 15-17 years were more likely than youth aged 12-14 years and adults aged 18-24 years were more likely than older adults to initiate P30D tobacco use across products; non-heterosexuals were more likely than heterosexuals to initiate P30D cigarette and ENDS use. Older adults were more likely than young adults, and males were more likely than females, to be frequent users of ENDS on initiation. Ever use of another tobacco product predicted P30D initiation of each tobacco product., Discussion: Other tobacco product use and age predict P30D tobacco initiation across products whereas associations with other demographic characteristics vary by product. Continued contemporary evaluation of initiation rates within the changing tobacco product marketplace is important., Competing Interests: Competing interests: WMC reports long-term stock holdings in General Electric Company, 3M Company, and Pfizer Incorporated, unrelated to this manuscript. No financial disclosures were reported by the other authors of this paper., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

The aim of health guidelines is to ensure consistency in the delivery of care to minimise health-related complications. However, even when good evidence is available, professionals do not necessarily implement it. Following a 2011 survey (Time 1) of staff in a tertiary maternity hospital, a number of service changes were implemented to facilitate best practice delivery of care to pregnant women regarding gestational weight gain (GWG). A (second) staff survey was then undertaken to re-assess staff knowledge, attitudes and behaviours around the management of GWG in our hospital. This cross-sectional, prospective online survey was distributed to staff in antenatal clinic. The survey assessed staff awareness of pregnancy-related weight complications, knowledge and application of specific guidelines, and a guideline adherence score was calculated. Sixty-nine staff (44.8% response rate) completed the 2014 (Time 2) survey. Just over half (51.9%) stated they were familiar with clinical guidelines regarding weight management in pregnancy. Guideline adherence ranged from 3.7 ± 1.9 to 11.3 ± 1.0 /15 across different professional groups; significant improvements with adherence by dietitians were noted over time. Despite minimal change over time in the overall adherence score, compliance with individual elements of the guideline recommendations comprising the adherence score differed. Improvements in staff practices and attitudes are apparent since the first survey. However, further improvements in guideline awareness and guideline elements are still required to improve the delivery of best practice antenatal GWG care., (© 2016 John Wiley & Sons Ltd.)