Kathleen Sanzo

Kathleen Sanzo

Morgan Lewis

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FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

3/25/2014 - Exclusive Dealing Agreements FDA Pharmaceutical Prescription Drugs

FDA Updates Reprint Guidance, Reiterates Narrowness of Off-Label Safe-Harbor

FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....more

3/7/2014 - Drug Manufacturers FDA Medical Devices Off-Label Promotion Prescription Drugs Safe Harbors

FTC Cracks Down on False Advertising in Dietary Supplements

Supplements making claims regarding diabetes, genetically customized nutritional benefits, and weight loss are slammed for false advertising. Recent Federal Trade Commission (FTC) enforcement activities—including a...more

2/27/2014 - Dietary Supplements False Advertising FDA FTC Weight-Loss Products

What Is That in Your Beverage? And Wait—Is It Really a Beverage?

FDA “reminds” manufacturers of the requirements for food and dietary supplement ingredients and finalizes long-awaited liquid dietary supplement guidance. On January 14, the U.S. Food and Drug Administration (FDA or...more

1/28/2014 - Dietary Supplements FDA Food Labeling

FDA Releases Good Manufacturing Practices for Animal Food

Proposed requirements dictate a substantial upgrade of the current regulatory standard of care. On October 29, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule—Current Good Manufacturing...more

11/1/2013 - FDA Food Safety FSMA Manufacturers

FDA Flexes Its FSMA Muscles, Initiates Mandatory Recall

Recall notification suggests the agency is ready and willing to use its new, enhanced enforcement authority. On February 13, the U.S. Food and Drug Administration (FDA) began its first enforcement action under the...more

3/13/2013 - FDA FSMA Notice Requirements Product Recalls

FDA Releases Major New Food Safety Proposals

Affected parties should familiarize themselves with proposed rules for safe food processing and handling and on-farm produce safety; comments to FDA are due by May 16....more

1/10/2013 - FDA Food Manufacturers Food Safety FSMA Preventive Control Rule

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