Predicting clinically significant drug interactions during drug development is a challenge for the pharmaceutical industry and regulatory agencies. Since the publication of the US Food and Drug Administration's (FDA's) first in vitro and in vivo drug interaction guidance documents in 1997 and 1999, researchers and clinicians have gained a better understanding of drug interactions. This knowledge has enabled the FDA and the industry to progress and begin to overcome these challenges. The FDA has continued its efforts to evaluate methodologies to study drug interactions and communicate recommendations regarding the conduct of drug interaction studies, particularly for CYP-based and transporter-based drug interactions, to the pharmaceutical industry. A drug interaction Web site was established to document the FDA's current understanding of drug interactions (http://www.fda.gov/cder/drug/drugInteractions/default.htm). This report provides an overview of the evolution of the drug interaction guidances, includes a synopsis of the steps taken by the FDA to revise the original drug interaction guidance documents, and summarizes and highlights updated sections in the current guidance document, Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling.

The value of quantitative thinking in drug development and regulatory review is increasingly being appreciated. Modeling and simulation of data pertaining to pharmacokinetic, pharmacodynamic, and disease progression is often referred to as the pharmacometrics analyses. The objective of the current report is to assess the role of pharmacometrics at the US Food and Drug Administration (FDA) in making drug approval and labeling decisions. The New Drug Applications (NDAs) submitted between 2000 and 2004 to the Cardio-renal, Oncology, and Neuropharmacology drug products divisions were surveyed. For those NDA reviews that included a pharmacometrics consultation, the clinical pharmacology scientists ranked the impact on the regulatory decision(s). Of about a total of 244 NDAs, 42 included a pharmacometrics component. Review of NDAs involved independent, quantitative evaluation by FDA pharmacometricians, even when such analysis was not conducted by the sponsor. Pharmacometric analyses were pivotal in regulatory decision making in more than half of the 42 NDAs. Of the 14 reviews that were pivotal to approval related decisions, 5 identified the need for additional trials, whereas 6 reduced the burden of conducting additional trials. Collaboration among the FDA clinical pharmacology, medical, and statistical reviewers and effective communication with the sponsors was critical for the impact to occur. The survey and the case studies emphasize the need for early interaction between the FDA and sponsors to plan the development more efficiently by appreciating the regulatory expectations better.

The COVID-19 infectious disease pandemic has caused significant fear and uncertainty around the world and had significant adverse psychological impact. Children, adolescents and adults with autism spectrum disorder (ASD) are a particularly vulnerable population, impacted by stay-at-home orders, closures at nonessential services, and social distancing standards. This commentary describes various challenges faced by individuals with ASD in the United States including disruptions caused by educational and vocational changes, challenges to home and leisure routines, limited access to behavioral health services and changes in health services delivery due to the pandemic. We highlight the need for ongoing skills development for individuals and development within systems to better respond to needs of the ASD population in future emergencies.

Background Awareness and use of electronic cigarettes (e-cigs) has increased significantly in the last five years, but little is known about the experiences, satisfaction, opinions and preferences of e-cigs users. Method 1177 participants completed an online survey about their electronic cigarette preferences, of which 200 were randomly selected for analysis. The data was analyzed using both qualitative and quantitative methods. Results Participants found the design, the ability to customize, and the quality of vapor to be the most important characteristics of the device. Participants thought the most positive aspects of e-cig use were help to quit smoking, improved overall health, and reduced cost. The negative aspects associated with use were mainly related to side effects, such as dry mouth. When asked to explain how e-cigs were used differently than cigarettes, participants reported puffing more regularly, but taking fewer puffs per session. Conclusions Experienced e-cig users stated that initiating e-cig use helped them to quit or reduce their conventional smoking, which they believe reduced their health risks. In comparison to cigarette smoking, e-cig users reported using their e-cig more times per day, but with fewer puffs at each use time. Users acknowledged that more research is needed to understand the safety and long-term effects of use. They mentioned dry mouth as a common side effect and common problems with reliability of e-cigs. Understanding these views may help health professionals to assess and assist e-cig users, and in the future, may help regulators to improve quality and reduce risks.