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Regulatory Requirements › Labeling › Manufacturers

Dorsey & Whitney LLP

New EU Packaging Rules Impact Manufacturers

Dorsey & Whitney LLP on

The Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40), the European Union’s new regulation concerning the packaging of products placed on the European market (PPWR), came into force on 11 February 2025....more

BakerHostetler

FDA Issues Draft Guidance on Replacing Color Additives in Drug Products

BakerHostetler on

On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more

Bergeson & Campbell, P.C.

CLP Changes And What They Mean For Commercial Operations — A Conversation with Karin Baron and Lioba Oerter

Bergeson & Campbell, P.C. on

This week I had the pleasure of speaking with Lioba Oerter, Director of Expert Services, 3E Expert Service Processing Centre (ESPC), and Karin F. Baron, Director of Hazard Communication and International Registration Strategy...more

Gardner Law

FDA Guidance for Labeling Plant-based Products

Gardner Law on

The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is...more

Sheppard Mullin Richter & Hampton LLP

Name That Chemical: California Adds New Requirement for Prop 65 Short-Form Warnings

Sheppard Mullin Richter & Hampton LLP on

Short-form warnings for products that may expose consumers to chemicals on California’s Prop 65 list must now include at least one chemical name to qualify for Prop 65’s “safe harbor” protections—with one caveat. Businesses...more

Perkins Coie

FDA Releases Draft Guidance on the Labeling of Plant-Based Foods

Perkins Coie on

The U.S. Food and Drug Administration (FDA) recently published draft guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods (Draft Guidance). The Draft Guidance recommends best practices for naming...more

Morgan Lewis - As Prescribed

Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule

Morgan Lewis - As Prescribed on

The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug products by allowing the approval of a nonprescription drug product with an “Additional Condition...more

Alston & Bird

Bringing Dietary Supplements to Market: Key Requirements and Best Practices

Alston & Bird on

Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. ...more

American Conference Institute (ACI)

[Event] Global Legal and Regulatory Summit On Biosimilars - December 3rd-4th, Munich, Germany

American Conference Institute (ACI) on

Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more

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