Risk Management Program for a New Formulation A medium-sized pharmaceutical company had received a non-approvable letter for a new formulation of a stimulant drug. One major deficiency was an inadequate Risk Management Program. Pinney Associates was contracted to develop the Risk Management Program on very short notice. Innovative approaches were designed to address novel issues, mitigate risks and enable rapid detection of potential problems in a very cost effective manner, and by approaches expected to be favorable to business development. The program was submitted to FDA and emerged as a strong point of the regulatory submission. FDA approved the medication soon after receiving the company's proposed Risk Management Program.
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