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If the Form 356h is missing information, the FDA will reply within 74 days. [3] A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number. Statutory standards for BLA approval are largely the same as those for New Drug Application approval.
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Alternatively, if If you think your article is ready but would like another editor to check it, you can submit it for review by an experienced editor by clicking the Submit the draft for review! button at the top of your draft. If the button isn't there, you can instead add {{subst:submit}} to the top of the draft. A reviewer will then look at ...