Gulfstream Daily Brief

Regulatory intelligence and policy · Issue 030

FDA finalizes biosimilar manufacturing guidance, EMA opens retinal dystrophy consultation

Today’s updates include final FDA actions on biosimilar manufacturing and standardized foods, plus an EMA consultation on inherited retinal dystrophies.

By Scott Morvay, Founder October 13, 2026 Official sources linked

FDA

FDA finalizes biosimilar manufacturing changes guidance

FDA issued final question and answer guidance on postapproval manufacturing changes for biosimilar and interchangeable biosimilar products. It finalizes the draft issued July 23, 2024.

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FDA

FDA permits salt substitutes in standardized foods

FDA issued a final rule amending standards of identity that specify salt as a required or optional ingredient, permitting salt substitutes to reduce sodium content while maintaining foods’ basic nature and essential characteristics.

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EMA

EMA opens consultation on inherited retinal dystrophy guideline concept

EMA opened consultation on a draft concept paper addressing the need for a guideline on clinical investigation of medicinal products for inherited retinal dystrophies.

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Why this matters

Regulatory teams now have final FDA positions to assess for biosimilar manufacturing changes and standardized food formulation. In Europe, the open EMA consultation provides an opportunity to review and comment on the proposed need for clinical investigation guidance in inherited retinal dystrophies.

Scott Morvay

Founder, Gulfstream Intelligence

This brief provides general regulatory news and educational information. It is not legal or regulatory advice.