Ensuring consistency in product quality: How FDA's requests for more info will be formalized
Making sure a pharma sponsor and the FDA are on the same page when it comes to a new drug development program, particularly around manufacturing, can be crucial to ensuring the drug gets a fair shake as the review process plays out.
One aspect of this dialogue is the agency may issue an information request (IR) via letter, email or fax — where FDA seeks a clarification to help its review.
But these IRs from CDER and CBER must be standardized, and adhere closely to what’s known as “Four-Part Harmony,” which is where reviewers are expected to communicate to sponsors: “(1) what was provided, (2) what is the issue or deficiency, (3) what is needed, and (4) why it is needed.”
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