The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...
You can expect several FDA audits throughout your drug development program The Agency’s goal is to protect the public from unsafe products, and one of the best ways to accomplish that goal is by...
Regulatory Sciences
Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic...
On Friday, October 12th, FDA issued a guidance document entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The document aims to help...
Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations (CROs). This ability to delegate through a Transfer of Regulatory...
The landscape of clinical trials is evolving. The changes that are happening are due to the increased number of FDA-regulated trials, as well as a rise in the complexity of clinical protocols. As...
In October 2009, the FDA issued a guidance document regarding its expectations for investigators during the conduct of clinical investigations.The guidance, entitled Investigator...
In 2004, the FDA issued a guidance document, entitled “Premarket Assessment of Pediatric Medical Devices.” The guidance stated that, when consistent with scientific principles, data can be...
A recent analysis by the Tufts Center for the Study of Drug Development places the price tag of bringing a new drug to market at around $2.6 billion. The reason for this is simple: failure. Drugs...
FDA recently updated its informed consent guidance in the form of an Information Sheet. The new document reflects the Agency’s current thinking on the informed consent process utilized in...