Pearls of Wisdom
FDA issues Draft Guidance for eCopy Program for Medical Device Submissions
On October 17, 2012, FDA announced another development in the MDUFA III implementation. The publication of the draft guidance on the eCopy program describes how FDA will initiate implementation once the guidance is finalized. An eCopy serves as the duplicate for the...
FDA weighs faster approval process for certain drug categories
The FDA is considering quicker U.S. approval for obesity treatments, life-saving antibiotics and other drugs believed to offer societal benefit despite their risks. Obesity not only affects one third of the U.S. adults but also the well-being of patients and is a...
MWDG devision of ASQ Biomedical presents “Human Factors in Medical Device Development” in Indianapolis
The Midwest Discussion Group (MWDG) of the ASQ Biomedical Division presents Human Factors in Medical Device Development on Thursday, October 25, 2012. Jim Kershner from Eli Lilly will share his experience dealing with issues around human factors in medical device...
Researchers turn to the web to accelerate the discovery of side effects
A recent article in The Wall Street Journal explained the innovative idea of using the web to monitor post-trial patients. The article shared that researchers can analyze patient comments in online chats and websites to watch for drug reactions. By monitoring the web,...
Breach of proposed drug shortage law could land you in prison for 3 years or fined up to $5million
A US bill aimed to stop price overcharging during drug shortages has proceeded to the Senate Committee stage. New York Senator Charles Schumer introduced the “Protecting Patients and Hospitals From Price Gouging Act” to put halt to suppliers, pharmas, and any party...