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Rejecting PhRMA's Request, US FDA Sticks With Size Over Function In Defining Biologic

 
• By Brenda Sandburg

Agency's final rule defines protein based on size of amino acid sequence, irrespective of method of manufacture, saying this 'bright-line rule' provides regulatory certainty.

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FDA issues final rule on definition of "biological product"

The Pharmaceutical Research and Manufacturers of America failed to convince the US Food and Drug Administration to define "protein" based on function, principally its method of manufacture, rather than the size of its amino acid sequence.

PhRMA made the request in comments to FDA on its proposed rule to amend the definition of "biological product" in the Public Health Service Act and its interpretation of what...

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