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Climate Smart, Sustainable Agriculture

By Marshall L. Matz and Peter B. Matz, as published in Agri-Pulse On September 29, the United Nations’ Food and...

Medical Devices, Pharmaceuticals and Food Products as Consumer Products – Additional U.S. and Canadian Regulatory Considerations

A Webinar Presented by OFW Law and Davis, LLP November 12, 2014, 1:00 p.m. EST During this webinar, attendees will...

Thirty Years of Hatch Waxman

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part I) Since its inception in 1979, OFW Law’s...

Data Driven Decision Making by Dr. Doom

When asked to visit an establishment to assess compliance, my first step is always to ask for data. Establishment food...

John Block Reports: Dietary Guidelines for Americans 2015 Edition – Losing It’s Way on Caffeine (Part I)

This week, OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block. There are...

How to Legally Import and Market Foods and Beverages in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP October 29, 2014, 1:00 p.m. EST During this webinar, attendees will...

Ask Not for Whom the Bell Tolls, it Tolls for Your LDT (Part I)

On October 3 of this year, the Food and Drug Administration (FDA) published draft guidance documents that, when finalized, will...

FDA To Hold Public Meeting on FSMA Supplemental Proposed Rules

The Food and Drug Administration (FDA) has announced a public meeting to be held on November 13, 2014 to discuss...

Settlement Agreement Reached on GRAS Notification Program Final Rule

By Mark L. Itzkoff On October 20, 2014, FDA and the consumer group called the Center for Food Safety (CFS)...

FDA Tweaks Its Four Foundational FSMA Proposed Rules

FDA has published supplemental proposed rules for the four “foundational” rules that will implement the Food Safety Modernization Act (FSMA)....

How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP October 15, 2014, 1:00 p.m. EST During this webinar, the second...

Consumers are Misled About Organic Safety

By John R. Block, as published in the Des Moines Register Every day millions of shoppers are paying out as...

What to Do After I Filed My Comment on FDA’s Proposed “Nutrition Facts” Labeling Regulations

Don’t sit back and wait: Be proactive! The comment period for FDA’s proposed regulations revising the “Nutrition Facts” label has...

Risk Communication about Methylmercury in Seafood

FDA has announced that its Risk Communication Advisory Committee (RCAC) will be holding a public meeting on November 3-4, 2014,...

How to Legally Import and Market Foods and Beverages in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP October 29, 2014, 1:00 p.m. EST During this webinar, attendees will...

FDA Food Facility Registrations Must Be Renewed Soon

It is October 1st and time to renew your food facility registration(s) with FDA. Facilities (domestic and foreign) engaged in...

How to Legally Import and Market Medical Devices in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP October 1, 2014, 1:00 p.m. EST During this webinar, the first...

Hatch-Waxman Turns 30 – A Stroll Down Memory Lane

Happy Birthday, Hatch-Waxman! You’re a mature 30-year old now, a regular adult. Some personal musings on my stroll down the...

Export Certificates for FDA-Regulated Foods Containing Egg Products as an Ingredient

The USDA’s Food Safety and Inspection Service (FSIS) plans, effective November 10, 2014, to halt issuing export certificates for FDA-regulated...

Africa Rising

By Marshall L. Matz, as published in the St. Louis Post-Dispatch According to Forbes Magazine, Mr. Strive Masiyiwa is the...

GMA Announces Initiative to Address Criticisms of GRAS Exemption

By Mark L. Itzkoff We have previously reported on criticism of the so-called “GRAS Exemption” and FDA’s GRAS Notification Program...

FDA Updates 4 Proposed Rules Implementing FSMA

The Food and Drug Administration (FDA) today made available proposed revisions to four (of seven) proposed rules implementing the FDA...

Webinar Series: Regulatory Requirements for the Import of Medical Products and Foods Into the U.S. and Canada

Announcing OFW Law and Davis LLP’s New Four-Part Webinar Series: REGULATORY REQUIREMENTS FOR THE IMPORT OF MEDICAL PRODUCTS AND FOODS...

How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP October 15, 2014, 1:00 p.m. EST During this webinar, the first...