The field of regulatory affairs deals with the regulatory requirements for marketing
authorization of therapeutic products. This field is facing a myriad of forces impacting all …

BACKGROUND Previous public health crises have changed medical product development
and regulatory practices. These examples include major legislative amendments and …

Purpose Critical steps have been adopted by health and regulatory authorities around the
world to respond to the COVID-19 pandemic. The authors aim to highlight these by providing …

The 21st century will be an unprecedented century of change in drug development and
regulatory science. With major technological advances, such as we've seen in genomics …

The pace of scientific progress over the past several decades within the biological, drug
development, and the digital realm has been remarkable. The'omics revolution has enabled …

Regulatory science is defined as science and research intended to inform decision making
in a regulatory framework. This issue of Clinical Pharmacology & Therapeutics and the …

Introduction: Despite advances in drug research and development, our knowledge of the
underlying molecular mechanisms of many diseases remains inadequate. This have led to …

Against the backdrop of the COVID pandemic, the scientific and medical communities are
working with all deliberate speed with state-of-the-art technologies to develop diagnostic …

The COVID-19 pandemic required urgency in the development and delivery of effective
vaccines and therapeutics; meanwhile, ongoing clinical research, regulation and supply for …

We present a commentary on the international aspects of the evolution of regulatory science
as a multidisciplinary, multistakeholder academic discipline of education and applied …