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…
- Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A Nerac Perspective, Part II: Selecting the Best Clinical Literature30By Richard Conforti, M.S., Nerac Analyst, Originally Published: June 14, 2016 In 2014 the Chinese Food and Drug Administration, CFDA, updated their regulations on medical devices. These updates substantially changed the way in which a medical device company, particularly international companies not based or founded in China, registers their devices in China. In part 2…