|
Mar 1, 2006
By:
Lou Morris
This letter concerns the FDA press release dated January 18, 2006, entitled "FDA Announces New Prescription Drug Information Format to Improve Patient Safety." The information contained is considered false and misleading, and lacking in fair balance.
|
|
Before FDA and industry can find a solution to DTC promotion, they need to nail down the problem.
Jan 1, 2006
By:
Lou Morris
Arguments over DTC have become more sophisticated, and there is much more middle ground.
|
|
FDA says every new drug needs a plan for dealing with risk.
May 1, 2004
By:
Lou Morris
Last year, FDA released a series of concept papers that summarized the agency's plans for risk management. One described a new mandate for the pharmaceutical industry: to develop a risk management plan (RMP) for each drug, to be submitted to FDA at the time of the new drug application. The concept papers still need to be finalized and converted into a guidance (a document that explains how companies may comply with FDA regulations), but the mandate is likely to go into effect this year.
|
|
PharmExec Blog
Follow Us
RSS
Bookstore
