Get Updates via E-mail. Enter your email address to automatically receive new posts to the FDA Law Blog via e-mail. Delivered by FeedBurner · Subscribe in a reader …. The Draft Guidance states that FDA prefers that reports be submitted with extensible markup language (“ XML ”) files in Structured Product Labeling (“SPL”) format . Information can be submitted by a link to a web portal on FDA's website. All in all, FDA's Draft Guidance seems to provide some clarity for …

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FDA Law Blog: FDA Releases Draft Guidance on Wholesale Drug …