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HTMLFDA Publishes Draft Guidance Documents on Compounding Using Bulk Drug Substances
Duane Morris LLP;
Legal Alert/Article
November 30, 2015, previously published on November 3, 2015
On October 27, 2015, the U.S. Food and Drug Administration (FDA) published notice of two draft guidance documents in the Federal Register[1]: “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act”[2] and “Interim...

 

HTMLFDA Publishes Three Major FSMA Final Rules
Edgar Asebey, Jonathan Berman, Colleen M. Heisey; Jones Day;
Legal Alert/Article
November 27, 2015, previously published on November 2015
On 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...

 

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...

 

HTMLFood-Contact Substances Subject to Final FSMA Foreign Supplier Verification Rule
Keller Heckman LLP;
Legal Alert/Article
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)....

 

HTMLFDA Explores Use of Term "Natural" on Human Food Labeling
Edgar Asebey, Jonathan Berman, Colleen M. Heisey, Katherine M. Llewellyn, Cristiana Spontoni; Jones Day;
Legal Alert/Article
November 27, 2015, previously published on November 13, 2015
FDA 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...

 

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...

 

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...

 

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.

 

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...

 


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