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Proposed Rules New Guidance Food and Drug Administration (FDA)

Akin Gump Strauss Hauer & Feld LLP

FDA Grants Three Natural Food Additive Petitions

On May 9, 2025, the U.S. Food and Drug Administration (FDA) granted three color additive petitions, approving two new colorings and expanding one existing approval. These approvals come after the agency’s announcement last...more

Smart & Biggar

Health Canada publishes Guide to the precision regulating authorities under the Food and Drugs Act

Smart & Biggar on

In March 2025,  Health Canada published a Guide to the precision regulating authorities under the Food and Drugs Act. The Guide sets out the principles, policies, considerations and standards that Health Canada should follow...more

Davis Wright Tremaine LLP

Flurry of Activity from FDA in the First Four Months of 2025

It is an understatement to say the last four months have been a whirlwind. Cabinet confirmations, executive orders, policy changes, and more, including some developments that impact (or that will impact) the food industry...more

Holland & Knight LLP

Holland & Knight Health Dose: December 13, 2022

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include: ...more

Hogan Lovells

Four new FDA guidances and proposed rule advance biosimilars policy framework

Hogan Lovells on

Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more

Goodwin

New FDA Biosimilar Guidances and Proposed Rule

Goodwin on

Today, the FDA issued four new biosimilar guidances, as well as a proposed rule. According to a statement by FDA Commissioner Scott Gottlieb, two of the guidance documents - the draft guidance titled “The ‘Deemed to be a...more

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