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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...

 

HTMLFDA to Host First Public Meeting on Biotech Regulation Overhaul
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
October 23, 2015, previously published on October 15, 2015
Today the Food and Drug Administration (FDA) posted notice of a public meeting to be held on Friday October 30th, in order to clarify the current roles and responsibilities described in the Coordinated Framework for the Regulation of Biotechnology and to develop a long-term strategy for the...

 

Adobe PDFStorm Clouds Gather: An FDA Proposal to Eliminate Generic Preemption
Joshua A. Hill; Butler Snow LLP;
Legal Alert/Article
October 21, 2015, previously published on Summer 2015
On March 18, 1925, the deadliest tornado in recorded history struck the United States. Later named the Tri-State Tornado, this merciless twister tore through parts of Missouri, Illinois and Indiana for over three hours. Traveling at speeds in excess of 70 miles per hour, the tornado carved a path...

 

Adobe PDFClassification: When “Equivalence” Means “Safety”
Erin P. Lane, Luther T. Munford; Butler Snow LLP;
Legal Alert/Article
October 21, 2015, previously published on Summer 2015
The FDA must clear most medical devices before they can be sold to the public. This article refutes a claim that the FDA’s process for clearing devices does not provide the “reasonable assurance of safety and effectiveness” Congress intended.

 

HTMLPacira Sues FDA, Alleging It Illegally Attempted to Restrict Truthful and Non-Misleading Speech about Its Post-Surgery Pain Drug Exparel
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
October 19, 2015, previously published on September 2015
The drugmaker filed a First Amendment suit seeking an injunction to prevent the regulator from taking enforcement action against it over what Pacira says is truthful and non-misleading promotion of Exparel, and alleging the FDA retroactively attempted to revise the drug’s label to limit its...

 

HTMLFDA Draft Guidance Describes Procedures, Policies for Resolving Scientific and Medical Disputes
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
October 19, 2015, previously published on September 2015
The agency issued guidance on the resolution of disputes that arise from disagreements between sponsors and the CDER or CBER, going over the procedures in the CDER and CBER for resolving scientific and/or medical disputes that can’t be settled at the decision level.

 

HTMLObama Administration Nominates Robert Califf as FDA Commissioner
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
October 19, 2015, previously published on September 2015
On Sept. 15, the Obama administration listed the nominees for several key administration posts, nominating Califf, a former Duke University researcher and deputy FDA commissioner for medical products and tobacco, as the next FDA commissioner.

 

HTMLIn Turnaround, California Abandons Restrictive "Made in USA" Standard
Nathan A. Cardon, Sheila A. Millar, Jean-Cyril Walker; Keller and Heckman LLP;
Legal Alert/Article
October 12, 2015, previously published on September 29, 2015
California Governor Jerry Brown (D) signed into law an amendment to the state's strictest-in-the-nation "Made in USA" law earlier this month. Previously, incorporation of any element that was foreign sourced -- even a single screw on a treadmill -- made an unqualified U.S.-origin claim...

 

HTMLFDA Releases Two Final Food Safety Rules: What You Need to Know
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
September 21, 2015, previously published on September 17, 2015
Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Food...

 

HTMLFDA Finalizes Food Safety Regs for Preventative Controls, Hazard Analysis
M. Antonio Gallegos, Justin J. Prochnow; Greenberg Traurig, LLP;
Legal Alert/Article
September 21, 2015, previously published on September 16, 2015
On Sept.10, 2015, the FDA announced two sets of final regulations which were mandated by the FDA Food Safety Modernization Act (FSMA) of 2011: (1) Preventative Controls and Hazard Analysis for Human Food; and (2) Preventative Controls and Hazard Analysis for Animal Food. The final regulations are...

 


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