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|FDA Publishes Draft Guidance Documents on Compounding Using Bulk Drug Substances|
Duane Morris LLP;
November 30, 2015, previously published on November 3, 2015On October 27, 2015, the U.S. Food and Drug Administration (FDA) published notice of two draft guidance documents in the Federal Register: “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act” and “Interim...
|Food-Contact Substances Subject to Final FSMA Foreign Supplier Verification Rule|
Keller Heckman LLP;
November 27, 2015, previously published on November 17, 2015 The U.S. Food and Drug Administration (FDA) made available on Friday, November 13, 2015, the pre-publication version of a final rule implementing the Foreign Supplier Verification Programs [FSVP] for Importers of Food for Humans and Animals provision of the FDA Food Safety Modernization Act (FSMA)....
|FDA Publishes Three Major FSMA Final Rules|
Edgar Asebey, Jonathan Berman, Colleen M. Heisey; Jones Day;
November 27, 2015, previously published on November 2015On November 13, 2015, the U.S. Food and Drug Administration ("FDA") published the three major rules affecting the food industry that it will adopt in 2015. These include final rules on Foreign Supplier Verification Programs ("FSVP"), Accredited Third-Party Certification, and...
|FDA Issues Three New Food Safety Rules|
Anna M. Wiand; GrayRobinson, P.A.;
November 27, 2015, previously published on November 16, 2015The 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...
|FDA Explores Use of Term "Natural" on Human Food Labeling|
Edgar Asebey, Jonathan Berman, Colleen M. Heisey, Katherine M. Llewellyn, Cristiana Spontoni; Jones Day;
November 27, 2015, previously published on November 13, 2015FDA is requesting public comments on (i) whether it is appropriate to define the term "natural" and, if so (ii) how the agency should define "natural," and (iii) whether it should determine appropriate use of the term on food labels. FDA considers a human food to be...
|FDA Seeks Comments on the Meaning of "Natural"|
Melvin S. Drozen, Alissa D. Jijon, Evangelia C. Pelonis; Keller and Heckman LLP;
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...
|FDA Requests Input on Use of the Term “Natural” for Foods|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
November 18, 2015, previously published on November 11, 2015On 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...
|FDA Releases Draft ICH Guidance with Aim to Improve Pharmaceutical Benefit-Risk Assessments|
Scott S. Liebman; Loeb & Loeb LLP;
November 10, 2015, previously published on Ocotber 2015The 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.
the Beef? Are Stricter Warning Label Requirements on the Horizon for the Meat
Kathleen D. Wilkinson; Wilson Elser Moskowitz Edelman & Dicker LLP;
November 10, 2015, previously published on November 5, 2015The 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...
|CDRH Looks to Keep Pace with New Technology, Bolster Patient Safety with 2016 Regulatory Science Priorities|
Scott S. Liebman; Loeb & Loeb LLP;
November 10, 2015, previously published on Ocotber 2015The 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...