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Biosimilar User Fee Agreement Includes “Financial Hold” On Development Programs For Failure To Pay

 
• By Sue Sutter

Biosimilar INDs could be placed on “financial hold” if sponsors fail to timely pay product development fees under FDA’s inaugural biosimilar user fee deal with industry.

Biosimilar INDs could be placed on “financial hold” if sponsors fail to timely pay product development fees under FDA’s inaugural biosimilar user fee agreement with industry.

Although the mechanism is characterized as a financial hold, it would appear to have the same effect as a clinical hold in that it would halt an ongoing biosimilar product...

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