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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.

 

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...

 

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...

 

HTMLLegislators Request Power Morcellator Investigation
Waters Kraus LLP;
Legal Alert/Article
September 10, 2015, previously published on September 9, 2015
Twelve congressional members have asked the U.S. Government Accountability Office to conduct an investigation concerning the laparoscopic power morcellator - a device used in gynecologic surgeries that can spread undetected cancer cells throughout the body. A bipartisan group of lawmakers sent a...

 

HTMLWhat’s in a Name? When You’re Selling a Food with an Established Federal Standard of Identity, a Whole Lot!
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
September 9, 2015, previously published on September 8, 2015
A bluntly labeled section of the Code of Federal Regulations - “Mayonnaise” - provides a description of this particular food dressing, the food’s required ingredients, optional ingredients, and how to declare those ingredients. The goals of this and other standardized food...

 

HTMLDrug Pumps Are Vulnerable to Hacking, FDA Warns
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
August 10, 2015, previously published on August 6, 2015
Last Friday, the Food and Drug Administration (FDA) issued a statement warning that certain drug infusion pumps that administer medication to patients are vulnerable to being hacked. The statement focused on the Symbiq Infusion System (Symbiq) manufactured by Hospira, Inc. Infusion pumps such as...

 

HTMLFDA Finalizes Guidance on Analytical Procedures and Methods Validation
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
August 5, 2015, previously published on July 2015
The recommendations contained in the guidance document concern drug products covered in NDAs, ANDAs, BLAs and supplements to those applications, and complement the ICH guidance “Q2(R1) Validation of Analytical Procedures: Text and Methodology.”

 

HTMLFDA Warns ASCEND Therapeutics for Excluding from Zazzle Card Serious Risks Associated with EstroGel Use
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
August 5, 2015, previously published on July 2015
EstroGel is indicated to treat “moderate to severe vasomotor symptoms due to menopause” and “moderate to severe symptoms of vulvar and vaginal atrophy due to menopause,” and its use is associated with a several serious risks, the FDA letter states. Boxed warnings are...

 


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