Articles by Lou Morris - Pharmaceutical Executive

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Articles by Lou Morris

Backpage: Warning Letter

Mar 1, 2006

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.

Backpage: Nailing Down DTC Promotion

Before FDA and industry can find a solution to DTC promotion, they need to nail down the problem.
Jan 1, 2006

Arguments over DTC have become more sophisticated, and there is much more middle ground.

The Risk Management Mandate

FDA says every new drug needs a plan for dealing with risk.
May 1, 2004

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.

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