FDA Cancels Registrations of Food Facilities That Were Not Renewed in Time

Some foreign food makers have recently found themselves unceremoniously purged from FDA’s database of registered facilities, and their products stopped at the port. Under the Food Safety Modernization Act (FSMA), all food facilities required to register with FDA must renew their registrations every two years, during the fourth quarter of every even-numbered year. The first […]

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FY 2012 Clinical Investigation Objectionable Activities/Enforcement Trends

FDA / OFW Law

Forewarned is forearmed. For FDA-regulated clinical investigations, knowledge of the most common violations cited by the agency upon inspection is a useful tool for examining one’s own procedures and practices. It helps ensure they are not vulnerable to the same deficiencies before FDA arrives at your investigational site. Pursuant to its Bioresearch Monitoring (“BIMO”) Program,

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FSMA Analysis, Webinar

FDA, OFW Law News / OFW Law

OFW Law has prepared comprehensive memoranda on two major FDA proposed rules, which FDA has characterized as the cornerstones of the new food safety system created by the Food Safety Modernization Act: Proposed Rule under FSMA for Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human

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FSMA Webinar

1 Comment / FDA, OFW Law News / OFW Law

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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Former USDA Official Janie Hipp Joins OFW Law as Of Counsel

OFW Law News, USDA / OFW Law

We are pleased to announce that Janie Hipp, Esq., formerly with the U.S. Department of Agriculture (“USDA”), will be joining OFW Law as Of Counsel. Hipp is a nationally recognized expert on Indian Law, with a focus on agriculture and energy policy, who served as Senior Advisor to Secretary of Agriculture Tom Vilsack. Please click the

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FSMA LIVES…..

FDA / OFW Law

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

FSMA LIVES….. Read More »

What Should an Establishment Consider in Controlling Pathogenic STECs?

USDA / OFW Law

As the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS) begins to conduct Food Safety Assessments (FSA) at beef slaughter establishments to verify controls for Pathogenic Shiga Toxin-Producing E. coli (STEC), establishments should ensure that they have systems in place that are effective for pathogenic STEC. Preventing contamination, effective use of interventions, and verification of the

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New Bill would Authorize Voluntary “Carcinogen-Free” Labeling of Food and Consumer Goods

Public Policy / OFW Law

By Mark L. Itzkoff A new bill introduced into the U.S. House of Representatives last month could eventually result in new labeling for food and other consumer products. H.R. 6601, The Carcinogen-Free Label Act of 2012 (CFLA) introduced last month by Rep. Theodore Deutch (D-FL) and Rep. Sue Myrick (R-NC), would require the U.S. Food and

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New CDC Study of Calories from Alcohol Supports Alcohol Beverage Label Reform

Miscellaneous / OFW Law

Alcohol accounts for a large portion of the daily calories consumed by many American adults, a new Centers for Disease Control and Prevention (CDC) study concludes. The study found 19 percent of men and 6 percent of women take in more than 300 calories daily from alcoholic drinks. “I think people may be aware that

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

FDA / OFW Law

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

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

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

FDA / OFW Law

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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California Prop 37 Fails to Pass

FDA, Public Policy / OFW Law

Among the casualties on election day this year was California Prop 37, defeated by a vote of 53% to 47%. Proposition 37, the California Right to Know Genetically Engineered Food Act, was a ballot initiative that would have required special labeling of foods that have been genetically engineered or contain genetically engineered ingredients. According to

California Prop 37 Fails to Pass Read More »

Here’s Your Chance to Fix the Budget

Public Policy / OFW Law

Content area

Here’s Your Chance to Fix the Budget Read More »

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

FDA / OFW Law

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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OFW Law’s John Block Participates in Panel of Former USDA Secretaries

OFW Law News / OFW Law

By John R. Block, Secretary of the U.S. Department of Agriculture from 1981-1985 Recently, I had the pleasure of joining three other former Secretaries of Agriculture at the University of Nebraska for a lively and informational discussion to celebrate the 150th anniversary of the Morrill Act, which created the land grant college system back in 1862. When

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California’s Prop 37 — A Prop Too Far?

FDA, Public Policy / OFW Law

Content area

California’s Prop 37 — A Prop Too Far? Read More »

FSIS Takes “Notice” Regarding Preventing Allergen Recalls

USDA / OFW Law

Content area

FSIS Takes “Notice” Regarding Preventing Allergen Recalls Read More »

OFW Law Drug and Health Care Privacy Practices

FDA, Health Care / OFW Law

Content area

OFW Law Drug and Health Care Privacy Practices Read More »

The FDA Regulatory Challenges of Software Interoperability and Part 806

FDA / OFW Law

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?

FDA / OFW Law

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

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

Abraham Lincoln’s Convention: Chicago 1860, by Kenneth D. Ackerman…Now Available!

OFW Law News / OFW Law

Abraham Lincoln’s Convention: Chicago 1860, compiled and presented by OFW Law’s very own Kenneth D. Ackerman, is now available! An eBook original and part of a series called History Shorts/Original Voices, it tells the story of Lincoln’s surprise nomination primarily through the eyes of newspaper writers, giving it the immediacy of the moment, with annotations, background,

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OFW Law

FDA Cancels Registrations of Food Facilities That Were Not Renewed in Time

FSMA Analysis, Webinar

FSMA Webinar

Former USDA Official Janie Hipp Joins OFW Law as Of Counsel

FSMA LIVES…..

What Should an Establishment Consider in Controlling Pathogenic STECs?

New Bill would Authorize Voluntary “Carcinogen-Free” Labeling of Food and Consumer Goods

New CDC Study of Calories from Alcohol Supports Alcohol Beverage Label Reform

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

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

California Prop 37 Fails to Pass

Here’s Your Chance to Fix the Budget

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

OFW Law’s John Block Participates in Panel of Former USDA Secretaries

California’s Prop 37 — A Prop Too Far?

FSIS Takes “Notice” Regarding Preventing Allergen Recalls

OFW Law Drug and Health Care Privacy Practices

The FDA Regulatory Challenges of Software Interoperability and Part 806

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

Abraham Lincoln’s Convention: Chicago 1860, by Kenneth D. Ackerman…Now Available!

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