Jonathan Havens

Jonathan Havens

Morgan Lewis

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FDA Proposes Food Defense Rule to Protect Against Intentional Adulteration

New mandate would apply to major U.S. and international food processors and handlers. On December 24, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule, Focused Mitigation Strategies to...more

1/6/2014 - FDA Food Contamination Food Safety

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 Issues Long-Awaited Final Guidance on Mobile Medical Applications

Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients. On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more

9/26/2013 - FDA Final Guidance Mobile Apps Mobile Devices Telemedicine

Final Sunshine Act Arrives: Now the Hard Part

The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more

3/8/2013 - Affordable Care Act CMS Healthcare Manufacturers Medical Devices Pharmaceutical Physicians Reporting Requirements Sunshine Act

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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