"The Strategic Role of the Regulatory Professional", Regulatory Focus

Read "Why Understanding Regulatory Affairs is Important to key Company Decision Makers" By Isabella Schmitt, RAC in the latest Regulatory (RF) Article Series.

"...early interaction with FDA is advisable as this will allow the company to avoid making any wrong assumptions about how the product will be regulated, as a premarket submission under a general product code may preclude the company from marketing toward a specific indication for use."

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Link to online RF (membership required)

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