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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...


Adobe PDFAlabama No Longer an Outlier State: Legislature Says “No” to Innovator Liability
Christopher S. Berdy, John H. Dollarhide, Ashley Nader Stubbs; Butler Snow LLP;
Legal Alert/Article
January 21, 2016, previously published on Fall 2015
Since the United States Supreme Court’s decision in Pliva, Inc. v. Mensing1, the plaintiffs’ bar has been feverishly searching for an alternate theory of recovery when the claimant took a generic prescription drug. One of those alternate theories is “innovator liability,”...


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 Provides Additional Warnings for SGLT2 Inhibitors
Law Offices of Peter G. Angelos A Professional Corporation;
Legal Alert/Article
December 10, 2015, previously published on December 7, 2015
In May, the United States Food and Drug Administration released information advising physicians and patients to be cautious about the risks related to SGLT2 inhibitors. Now, the FDA has updated the warning label for the drugs to include the risk of ketoacidosis and severe urinary tract infection.


HTMLFDA Publishes Revised Guidance on Product Tracing Requirements for Dispensers
Carolyn A. Alenci, Rachael G. Pontikes; Duane Morris LLP;
Legal Alert/Article
November 30, 2015, previously published on November 4, 2015
On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted “to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed in the United States.” This year, trading partners were...


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...


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