Why is naming a drug so difficult?

In February 2010 the FDA published “Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names” (Guidance), which describes in detail the FDA’s evaluation methodology for proposed proprietary drug names.  By carefully...

Blockbuster Drug Potential: Importance of Risk Management

Prior to drug approval, a potential new drug is usually subjected to the scrutiny of an expert advisory panel, selected by the FDA, who recommend whether or not the product should be marketed.   These recommendations are non-binding.  Industry analysts looked at...

Genetic Toxicology: Historical and Current Perspectives

Fundamentals Of Genetic Toxicology In The Pharmaceutical Industry Sept 2010 View more presentations from TigerTox. Historical Overview During the past 30 years, genetic toxicology testing has evolved technologically to play an important safety assessment role in the...

New FDA Postmarketing Drug Safety Evaluation Website

As of 15 June 2010, the new Food and Drug Administration (FDA) Postmarketing Drug Safety Evaluation website was launched.   The FDA posted postmarket safety evaluations for 26 drugs approved between September 2007 and January 2008 and is reviewing an additional 20 or...