AG/FDA Blog

FDA implements 21st Century Cures Act Requirements for Reusable Devices

Last week, the Food and Drug Administration (“FDA”) published a notice in the Federal Register implementing additional requirements for medical devices under the 21st Century Cures Act (“Cures Act”).   Section 3059 of the Cures Act requires… Read More
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Think This is Biotech Regulatory Relief? Not Yet.

By Dr. Nina Fedoroff, as published in Agri-Pulse USDA and FDA proposals to regulate genetically engineered (GE) plants and animals following the recent update of the regulatory framework are on their websites awaiting public comment by June 19, 201… Read More
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FDA Announces Intent to Extend the Compliance Date for New Nutrition Facts Rules

This morning, FDA’s Office of Nutrition and Food Labeling announced that it intends to extend the compliance date for the new Nutrition Facts requirements.  FDA’s announcement, which is included on its “Changes to the Nutrition Facts Label”… Read More
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FDA Implements 21st Century Cures Requirements for Devices

Today’s Federal Register announces a technical amendment to FDA’s regulation of medical devices to align the regulations with the the Food, Drug, and Cosmetic Act (FD&C Act).  The 21st Century Cures Act became law on December 13, 2016, and a… Read More
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NYC Menu Labeling Law – Enforceable?

NYC just announced that its revised calorie labeling rule for food service establishments will take effect on May 22, 2017, and will begin being enforced with notices of violation subject to fines on August 21, 2017.  This pre-dates the recently re-… Read More
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FDA Extends Menu Labeling Compliance Date One Year Consistent with Trump Administration Policy

FDA is again extending the compliance date for menu labeling – just days before the regulatory requirements of § 101.11 were to have become effective.  On May 4, 2017, the agency will publish an interim final rule that extends the compliance date… Read More
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Delay of FDA Menu Labeling Regulation Provides Blueprint for Modification of Nutrition Labeling Rules

The restaurant industry was bracing for FDA’s menu labeling regulation, requiring mandatory calorie disclosure on menus at chains that have 20 or more locations.  The final compliance date was coming up next week on May 5, 2017.  However, in a la… Read More
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I’m a FSVP Importer: How Do I Know When I Need To Comply?

That is one of the most common – and difficult – questions to answer when OFW Law teaches a Food Safety Modernization Act Foreign Supplier Verification Programs (FSMA FSVP) course.  Determining the compliance dates is typically more chal… Read More
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The Relatively Unknown FSMA Rule – Foreign Supplier Verification Programs Rule

FSMA – The D.C. acronym for the Food Safety Modernization Act.  When I am working with clients or speaking with industry, everyone is familiar with FSMA.  But they think of FSMA as the Preventive Controls or Produce Safety Rules.  Some are also… Read More
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OFW Law Supports Medical Device Innovators at the 2017 Rice Business Plan Competition

On April 8, 2017, Forest Devices, Inc. from Carnegie Mellon University was awarded OFW Law’s Regulatory Strategy Prize at the 2017 Rice Business Plan Competition in Houston, Texas.  Forest Devices bested 41 other competitors hailing from some of t… Read More
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