Topic: Center for Drug Evaluation and Research

Richard L. FriedmanA Podcast Inteview. Regulators and industry professionals are working together to implement new approaches to secure the drug...
This post is a long one but I promise it's worthwhile for the Arena (ARNA) crowd. In order to more accurately determine the potential outcome of...

New Generic Drug Program: Q & A with Gary J. Buehler

Gary J. Buehler, RPh., is Director of the Office of Generic Drugs (OGD) in FDA's Center for Drug Evaluation and Research (CDER). A graduate of Temple University's School of Pharmacy, Mr. Buehler joined FDA in 1986 and retired from the ...

FDA Action on Unapproved Hydrocodone Products

On Sept.28, 2007, FDA announced its intention to take enforcement action against companies marketing unapproved prescription drug products containing hydrocodone, a narcotic widely used to treat pain and suppress coughs. The action does not affect other h