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HTMLNYS Appellate Court Upholds Executive Compensation Order and Regulations: What Happens Next?
Harold N. Iselin, Joshua L. Oppenheimer, Francis J. Serbaroli; Greenberg Traurig, LLP;
Legal Alert/Article
February 2, 2016, previously published on January 19, 2016
On Dec. 30, 2015, the New York State Appellate Division, Second Department upheld the validity of Governor Cuomo’s Executive Order pertaining to executive compensation and administrative expenses of certain service providers (EO 38), as well as the implementing regulations. This was the first...

 

HTMLObama Administration Releases New Dietary Guidelines Focusing on Limiting Sugar
Edgar J. Asebey, Jonathan Berman, Colleen Heisey, Katherine M. Llewellyn, Cristiana Spontoni; Jones Day;
Legal Alert/Article
January 19, 2016, previously published on January 2016
The Obama administration has released the updated Dietary Guidelines for Americans with a new focus on limiting sugar. The Guidelines are revised every five years by USDA and the U.S. Department of Health and Human Services ("HHS"), based largely on advice from the Dietary Guidelines...

 

HTMLRegulation of Laboratory Developed Tests: What Will FDA Do Next?
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
January 14, 2016, previously published on December 29, 2015
When FDA released in October 2014 a draft guidance document that set forth its plans for regulating LDTs pursuant to its authority over in vitro diagnostics (IVDs), the agency set the stage for controversy in 2015. Historically FDA has exercised its enforcement discretion and elected not to...

 

HTMLFDA Explores Use of Term "Natural" on Human Food Labeling
Edgar J. Asebey, Jonathan Berman, Colleen 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 Holds Back-to-Back Workshops on Next-Generation Sequencing Diagnostic Tests
Edgar J. Asebey, Maureen Bennett, Christian B. Fulda, Colleen Heisey, Cristiana Spontoni; Jones Day;
Legal Alert/Article
November 27, 2015, previously published on November 2015
Last week, FDA held two workshops to gather information on developing a flexible approach for the regulation of next generation sequencing ("NGS") in vitro diagnostic tests. NGS tests facilitate the rapid sequencing and analysis of segments of DNA, yielding information that can be used to...

 

HTMLMylan Agrees to Divest Seven Products, Including Three Pipeline Products, to Clear FTC Hurdle in Its $27 Billion Tender Offer Bid for Perrigo
Timothy J. Slattery; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
November 18, 2015, previously published on November 6, 2015
The Federal Trade Commission (“FTC”) yesterday concluded its antitrust review of Mylan N.V.’s (“Mylan”) proposed acquisition of Perrigo Company plc (“Perrigo”) by entering into a proposed consent judgment that would require Mylan to divest seven generic...

 

HTMLFTC-DOJ Join Forces: Encourage Repeal/Retrenchment of Virginia CON Laws
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
October 30, 2015, previously published on October 27, 2015
The Federal Trade Commission (“FTC”) and Department of Justice Antitrust Division (“DOJ”) (collectively, “agencies”) issued a joint statement to Virginia’s Certificate of Public Need (“COPN”) Work Group, which was recently charged with reviewing...

 

HTMLFTC Submits Public Comments to States Considering Regulations of Cooperative Agreements Between Hospitals
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
October 23, 2015, previously published on October 19, 2015
The Federal Trade Commission (FTC) recently submitted comments to Virginia and Tennessee regarding proposed laws in each state relating to Cooperative Agreements between hospitals and the granting of Certificates of Public Advantage (COPA). This continues the FTC’s active monitoring of state...

 

HTMLFTC Provides Guidance Regarding Antitrust Compliance for State Regulatory Boards
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
October 22, 2015, previously published on October 19, 2015
In North Carolina State Board of Dental Examiners v. FTC, 135 S. Ct. 1101 (2015), the Supreme Court held that the North Carolina Board of Dental Examiners (“Board”), a state agency, was not exempt from federal antitrust laws when it prohibited non-dentists from providing teeth whitening...

 

HTMLFDA Indicates Shared Nonproprietary Names Not Appropriate for All Biological Products, Including Biosimilars
Edgar J. Asebey, Maureen Bennett, Colleen Heisey, Janet M. McNicholas, Christian Paul; Jones Day;
Legal Alert/Article
September 11, 2015, previously published on September 2015
On August 28, 2015, the U.S. Food & Drug Administration ("FDA") released a draft guidance document describing its current position on biological product nonproprietary naming, including the need for biological products to bear a nonproprietary name to which is attached an...

 


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