THOUGHT LEADERSHIP

Emerging biotech companies must master many challenges in bringing a product to market. Even the acronyms common to early development, like IND (Investigational New Drug Application), SAD (single ascending dose), and MAD (multiple ascending dose) imply that a company must know how their treatment impacts the body, how to analyze study results, and how to express their findings to regulatory authorities. The expertise of medical writers is valuable in helping an emerging biotech reach its drug development goals.

The development of the Package Insert (PI), also known as the Product Information, Prescribing/Prescriber’s Information, or simply “the Label,” is a long, complex process typically managed by a regulatory professional. It is a collaborative document, incorporating contributions from chemistry, toxicology, medical/clinical, biostatistical, writing, and regulatory professionals. Drawing from experience on a recent project, I would like to focus this installment of Protocol to Package Insert on the derivation of the clinical safety data that appear in the PI.