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Sunscreen Quality, Safety and Efficacy

Sunscreen Quality, Safety and Efficacy

New Initiatives by FDA FDA has proposed revisions and updates to OTC-drug sunscreen requirements related to maximum sun protection factor (SPF) values, active ingredients, broad-spectrum requirements, and product labeling, among other provisions. This effort aims to...
FDA Finalizes Two Foundational PMTA Rules

FDA Finalizes Two Foundational PMTA Rules

U.S. Food and Drug Administration has issued two final rules for the premarket review of new tobacco products, providing additional information on the requirements for the content, format and review of Premarket Tobacco Product Applications (PMTAs) and Substantial...
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...