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HTMLFDA Issues Three New Food Safety Rules
Anna M. Wiand; GrayRobinson, P.A.;
Legal Alert/Article
November 27, 2015, previously published on November 16, 2015
The U.S. Food and Drug Administration (FDA) finalized three new food safety regulations for produce farms and imported foods. The new rules are a major component of the Agency’s efforts to reduce the risks of foodborne illnesses, and implement the bipartisan Food Safety Modernization Act of...


HTMLFDA Seeks Comments on the Meaning of "Natural"
Melvin S. Drozen, Alissa D. Jijon, Evangelia C. Pelonis; Keller and Heckman LLP;
Legal Alert/Article
November 20, 2015, previously published on November 11, 2015
As food industry stakeholders are well aware, the use of the term “natural” in food labeling and advertising is fraught with ambiguity and risk of challenge. FDA’s informal policy is that “natural” means nothing artificial or synthetic (including all color additives...


HTMLFDA Requests Input on Use of the Term “Natural” for Foods
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
November 18, 2015, previously published on November 11, 2015
On November 12, 2015, FDA is scheduled to publish a notice in the Federal Register announcing a request for public comments on the use of the term “natural” in food labeling. As the Agency points out, it has been under pressure in recent years from many stakeholders to develop a...


HTMLWhere’s the Beef? Are Stricter Warning Label Requirements on the Horizon for the Meat Industry?
Kathleen D. Wilkinson; Wilson Elser Moskowitz Edelman & Dicker LLP;
Legal Alert/Article
November 10, 2015, previously published on November 5, 2015
The World Health Organization (WHO), the United Nations’ public health arm, issued a report on October 26, 2015, based on research performed by the International Agency for Research on Cancer (IARC), linking cancer to consumption of red meat and processed meat. In the report, 22 world health...


HTMLCDRH Looks to Keep Pace with New Technology, Bolster Patient Safety with 2016 Regulatory Science Priorities
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
November 10, 2015, previously published on Ocotber 2015
The regulatory science priorities for FY2016 focus on the integration of new technology, including “Big Data,” into the regulatory decision-making process, with a particular emphasis on patient safety and experience. The priorities reflect a more patient-centric approach to...


HTMLFDA Releases Draft ICH Guidance with Aim to Improve Pharmaceutical Benefit-Risk Assessments
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
November 10, 2015, previously published on Ocotber 2015
The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory submissions. The guidance doesn’t call for a particular approach, but specifies what elements should be included in submissions.


HTMLFDA Draft Guidance Outlines Appropriate Labeling for Injectable Drug Doses
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
November 10, 2015, previously published on Scott Liebman
The FDA released draft guidance on how to label injectable drugs for their appropriate doses, offering a new definition of single- and multiple-dose containers and replacing the term “single-use” with “single-patient-use.” Sponsors are being tasked with updating their labels...


HTMLU.S. Reaches One of the Largest Trade Agreements in History: the TPP
Edgar J. Asebey, Jonathan Berman, Colleen Heisey, Katherine M. Llewellyn, Cristiana Spontoni; Jones Day;
Legal Alert/Article
October 28, 2015, previously published on October 2015
On October 6, 2015, after five years of negotiations, the U.S. closed the Trans-Pacific Partnership ("TPP") deal with Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam. According to Agriculture Secretary Tom Vilsak, "[T]he agreement...


HTMLChina's New Food Safety Law Became Effective Oct. 1: Are You in Compliance?
Keller Heckman LLP;
Legal Alert/Article
October 27, 2015, previously published on October 9, 2015
October 1st was an important day for any company in the food industry doing business in China.That is when the Food Safety Law [1](FSL) became effective.As you may recall, on April 24, 2015, in response to several high-profile food safety scandals and the need to harmonize with the global practice...


HTMLXarelto Dangers Investigated in Canada
Waters Kraus LLP;
Legal Alert/Article
October 26, 2015, previously published on October 12, 2015
The Canadian government has recently initiated a probe into the dangers associated with the blood thinner Xarelto (rivaroxaban). In July 2011, the U.S. Food & Drug Administration (FDA) approved the anti-clotting agent for patients receiving knee and hip replacements, to prevent strokes. Later...


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