Anneke Baran Altieri

Anneke Baran Altieri

Hogan Lovells

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FDA Draft Guidance Addresses Management of Environmental Pathogen Hazards for Low-Moisture Ready-to-Eat Foods

On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a...more

1/13/2025  /  CGMP , Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Manufacturers , Public Health , Risk Management

FDA Releases Revised Appendix 1 and Introduction to Hazard Analysis and Preventive Controls Draft Guidance

The U.S. Food and Drug Administration (FDA) recently released an update of its multi-chapter draft guidance, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft...more

3/19/2024  /  Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply

Two recent developments regarding FDA inspection-related activities

The United States Food and Drug Administration (FDA) recently announced two developments on inspection-related activities providing insight into FDA’s perspective on the legal obligations that apply to food facilities, and...more

11/7/2022  /  Draft Guidance , FDA Warning Letters , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , Inspections

FDA issues draft guidance on remote regulatory assessments

DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records. FDA outlines how it intends this tool to be incorporated...more

8/4/2022  /  Beverage Manufacturers , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Regulatory Agenda , Regulatory Oversight , Regulatory Requirements

FDA Issues Draft Guidance on Evaluating Public Health Impacts from Non-Major Food Allergens

The U.S. Food and Drug Administration (FDA) recently published draft guidance that explains the approach the agency intends to take when evaluating the public health importance of food allergens that are not one of the nine...more

5/9/2022  /  Draft Guidance , Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) , Food Allergies , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Food Supply , Public Health

FDA issues draft guidance on oversight of food products covered by Systems Recognition Arrangements

For the past several years, the U.S. Food and Drug Administration (FDA) has used a “Systems Recognition” approach with its foreign regulatory counterparts, through which the FDA evaluates whether its foreign counterpart...more

7/19/2021  /  Dietary Supplements , Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Imports , Regulatory Oversight
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