FDA

FSMA Webinar

January 24, 2013 – 12pm ET Hazard Analysis & Preventive Controls for Human Food OFW Law and The Food Institute, the best “single source” for information about the food industry, will present a 90-minute webinar on Thursday, January 24, 2013, to explore the proposed rule, issued on January 4 by the Food & Drug Administration (FDA). This FDA proposed rule …

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Is Standardized Device Labeling On The Way?

Changes could be coming for medical device labeling regulations.  On January 7, 2013, the Food and Drug Administration (“FDA”) announced in the Federal Register a public workshop and solicitation of comments concerning “Accessible Standardized Medical Device Labeling.” The Federal Register notice can be viewed here and the public workshop will be held on April 29 and …

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FSMA LIVES…..

On January 4, 2013, the second anniversary of the enactment of the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) released two important proposed rules to implement the new law.  After such a long detour at the White House Office of Management and Budget, the release caught many of us by …

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Are These Substances “Natural?” Class Action Lawsuits Target Specific Ingredients

Consumer class action cases challenging “All Natural” or “100% Natural” claims on food labels are popping up about as fast as dandelions in springtime.  Such cases are typically brought under state consumer protection laws prohibiting, inter alia, false or misleading food labeling and advertising.  Some of these laws, such as those in California and New …

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Everyone has an Opinion on Unique Device Identification

When the comment period closed on November 7, the Food and Drug Administration’s (FDA) proposed rule on Unique Device Identification (“UDI”) generated a total of 221 comments by various stakeholders.  Although the FDA has come a long way since it first sought comments on the use of an identifier system in 2006, a review of the comments …

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Compounding, Again

The election is over, cabinet re-shuffling has begun, and hopefully you properly prepared and stored your food and avoided poisoning family and friends over the Thanksgiving holiday.  As you can imagine, food preparation at a food and drug law firm is a very serious business.  We regularly swap favorite turkey brining and stuffing recipes and …

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Food Labeling Politics – What the Election Results May Mean for Your Company

The election is over and the current Administration will stay in the White House. Food labeling may not have been among the top issues on the minds of American voters.  But the election results will have an impact on food manufacturers, retailers, and restaurant operators who are concerned about the prospect of new FDA regulations, …

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Can FDA Regulate Compounding? FDA Doesn’t Think So. . . But It Kind of Tried To

As the impact of the deadly meningitis outbreak grows, questions about FDA’s authority to regulate pharmacy compounding have arisen. New England Compounding Center Inc.’s (NECC) tainted, injectable steroid, methylprednisolone acetate, is now linked to 461 infections, including 32 deaths.  In testimony this week before the House Energy and Commerce Subcommittee on Oversight and Investigations, FDA …

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BPA: The Press Rounds Up the Usual Suspects and Gets it Wrong

By Mark L. Itzkoff Over the past few months, articles have been published claiming possible links between bisphenol A (BPA) and a variety of human health problems including obesity, thyroid changes, and male infertility.  Many of the recent stories leave consumers misinformed about possible exposure to BPA and implicate products that do not contain BPA. For example, NBC News …

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The Waiting Game

It’s been a weird week.  The “Frankenstorm” also known as Sandy blew through Washington, closing everything from the stalwart federal government to the Metro system.  OFW Law weathered the storm pretty well, though the view outside my window of the muddy, debris-filled Potomac is an ever-present reminder that our problems pale in comparison to those …

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Safety v. Innovation – How the European Commission’s Proposed Regulation Hopes to Strike the Right Balance

By Kathryn E. Balmford Back in January, Jeff Shuren, M.D., the Director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA), made headlines when comparing the European Union’s (EU) regulation of medical devices to FDA’s.  When asked by a reporter whether proposed changes to FDA’s 510(k) premarket clearance system …

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Class Action Consumer Litigation: A Rising Enforcement Risk for Aggressive Food Labeling Claims

The number of class action lawsuits targeting food labeling claims has risen dramatically over the past few years.  These are cases alleging that a food product’s labeling (and/or advertising) violates state consumer protection laws.  As a result, when a food company now considers whether to include an aggressive claim in commercial marketing, it should consider …

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The FDA Regulatory Challenges of Software Interoperability and Part 806

By Casper E. Uldriks The verification of design specifications and functional validation of software is predicated on its intended use with a particular device or as a “stand alone” device. The U.S. Food and Drug Administration (FDA) and the industry have understood and used software validation principles ever since the enactment of the Medical Device …

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What’s Important in Assessing the Need for Additional 510(k) Clearance for Medical Device Changes?

Medical device companies often find themselves in a bind if the U.S. Food and Drug Administration (FDA) scrutinizes their decisions that product changes did not trigger the regulatory requirement for a new 510(k) submission for the changed device. They often use a thought process that is unacceptable to FDA. In other cases, they do not …

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