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HTMLFTC Plants A Flag With LabMD Ruling: What This Means for Enforcement
Cynthia J. Larose, Natalie Prescott; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
August 15, 2016, previously published on August 1, 2016
On Friday, the heads of the Federal Trade Commission overruled the decision of the Administrative Law Judge (“ALJ”) in In the Matter of LabMd., Inc. The FTC concluded that the ALJ had erred in dismissing the Commission’s case against a lab testing company LabMD and misapplied the...

 

HTMLFTC Granted 2-Week Reprieve in Effort to Block Pennsylvania Hospital Merger
Farrah Short; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 17, 2016, previously published on May 13, 2016
The Federal Trade Commission (“FTC”) and the state of Pennsylvania have two weeks to persuade the Court of Appeals for the Third Circuit that the pending merger of Penn State Hershey Medical Center (“Hershey”) and Pinnacle Health System (“Pinnacle”) is...

 

HTMLAmarin and FDA Agree to Landmark Settlement on Off-Label Promotion
Michael A. Carvin, Toni-Ann Citera, Colleen Heisey, Karen P. Hewitt, Laura F. Laemmle-Weidenfeld; Jones Day;
Legal Alert/Article
April 6, 2016, previously published on March 2016
On March 8, 2016, Amarin Pharma, Inc. reached a noteworthy settlement in its lawsuit against the U.S. Food and Drug Administration ("FDA") to protect its First Amendment right to promote the drug Vascepa for nonapproved, off-label uses. Amarin Pharma, Inc. v. FDA (S.D.N.Y. No. 15-cv-3588)...

 

HTMLFTC Again Urges Consideration of Competitive Impact on State Regulation of APRNs
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
February 25, 2016, previously published on February 17, 2016
The Federal Trade Commission (FTC) submitted written comments last week on the likely competitive impact of a legislative proposal in West Virginia to modify the supervision requirements imposed on Advanced Practice Registered Nurses (APRNs) for certain activities. The legislative proposal would...

 

HTMLSafety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
February 11, 2016, previously published on January 26, 2016
FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and Pensions (HELP) Committee staff reported on systemic failures in...

 

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...

 


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