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Combo Product Consultations At US FDA May Suffer As They Become Formalized

 
• By Michael Cipriano

Brad Thompson says that phone calls used in current informal process help sponsors understand Office of Combination Product’s thinking, and that a formalized process envision in the new draft guidance could make this dialogue more difficult.

The US FDA’s new draft guidance for combination product sponsors on how to prepare a Pre-Request for Designation (Pre-RFD) may in fact be a step backwards in terms of convenience and value for developers compared to the current informal process, according to one expert.

Brad Thompson, an attorney with Epstein Becker & Green, tells the Pink Sheet that the current informal process of calling...

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