the adoption and use of digital forms of direct-to-consumer advertising (also known as “edtca”) is on the rise. at the same time, the universe of edtca is expanding, as technology on internet-based platforms continues to evolve, from static websites, to social media, and nearly ubiquitous use of mobile devices. however, little is known about how this unique form of pharmaceutical marketing impa...

In an Editorial of Science in 2011, Margaret A. Hamburg, the then Commissioner of the US Food and Drug Administration highlighted that a strong field of regulatory science is required to develop new tools, standards and approaches that efficiently and consistently assess the safety, efficacy and performance of products, and that this field has long been underappreciated and underfunded.1 During...

The global regulatory plan for vaccines provides a unique opportunity to develop safe and effective ones with assured quality. Methods used by regulators address challenges of new products and technologies and also increase understanding of benefits and risks of existing products. First, the laboratory-based regulatory sciences evolve correlates of immunity and safety; or improve the product ch...