8 Sep, 2010
“Brilliant, penetrating, and chillingly accurate.” — John Hammill, International Advocates for Health Freedom “A must-read for anyone who wants the truth about how greed and corruption are dominating healthcare in America.” — Kevin P. Miller, In.. Continue Reading>>
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality syst.. Continue Reading>>
3 Jul, 2010
A watch list of 13 drugs based on potential signs of serious risks or new safety information collected by the Adverse Event Reporting System (AERS) of the US Food and Drug Administration (FDA) during the first quarter of 2010 has been released.
The FDA is studying all of the drugs to determine the n.. Continue Reading>>