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June Drug Registration / Listing

June Drug Registration / Listing

As you are probably aware, per 21 CFR 207.57 FDA drug establishment registrants must review and, if necessary, update listing information each June and December. This includes all drug listings, including bulk products. EAS provides support with facility registrations...
June Drug Registration / Listing

Sesame Allergen Declaration

On April 14, 2021 the US House of Representatives passed a bill (S. 578) entitled the “Food Allergen Safety Treatment Education and Research ACT” designating sesame as a major food allergen, and directing the Secretary of Health and Human Services to submit a report...