By Stephen Buxser, Ph.D., Nerac Analyst,
Originally Published: November 28, 2016
For drugs licensed for sale in the United States, as well as elsewhere in the world, there are requirements for periodic literature updates/reviews. These reviews require resources to capture all scientific publications describing health or safety issues for a particular drug during a specified time period. Although such reports have been a part of the landscape for marketed drugs for many years, the procedures for carrying out the searches have not been particularly clear. This article describes the legal requirements for drug safety and efficacy reporting.
- 42New issue explores innovations in cancer treatments, graphene and drug safety updates. Read the full release here.
- 36By Joanne Ferrell and John Leavitt, Ph.D. Originally published October, 2013 Pharmacovigilance: What is it and why is it important? The requirements regarding post-market safety monitoring are more stringent now than ever. Numerous incidents involving marketed pharmaceuticals and over-the-counter (OTC) medicines in recent years have brought the issues of safety monitoring and risk management to…
- 30New release offers in-depth business perspectives on industry issues, compliance challenges and commercial opportunities authored by Nerac analysts Read the full release here.