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HTMLIs Your Website ADA-Compliant? Does It Need to Be?
Ed Chansky, Robert S. Fine, Erica Okerberg; Greenberg Traurig, LLP;
Legal Alert/Article
November 10, 2015, previously published on November 5, 2015
Title III of the Americans with Disabilities Act (ADA) requires any “place of public accommodation” to be accessible to persons with disabilities. The ADA does not directly define “place of public accommodation.” Instead, it sets forth a long list of examples, such as...


HTMLFDA Releases Draft ICH Guidance with Aim to Improve Pharmaceutical Benefit-Risk Assessments
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
November 10, 2015, previously published on Ocotber 2015
The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory submissions. The guidance doesn’t call for a particular approach, but specifies what elements should be included in submissions.


HTMLCDRH Looks to Keep Pace with New Technology, Bolster Patient Safety with 2016 Regulatory Science Priorities
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
November 10, 2015, previously published on Ocotber 2015
The regulatory science priorities for FY2016 focus on the integration of new technology, including “Big Data,” into the regulatory decision-making process, with a particular emphasis on patient safety and experience. The priorities reflect a more patient-centric approach to...


HTMLSupreme Court to Review Federal Circuit Test for Willful Patent Infringement
Paula K. Colbath, Kathleen M. Gersh; Loeb & Loeb LLP;
Legal Alert/Article
October 26, 2015, previously published on October 2015
The U.S. Supreme Court will review the Federal Circuit’s test for determining willful patent infringement at the request of two patent holders that assert that the two-part test is too rigid and conflicts with the recent Supreme Court decision in Octane Fitness.


HTMLCJEU Decides on Calculation of SPC Term
Christian B. Fulda, Tetiana Kharkovets; Jones Day;
Legal Alert/Article
October 23, 2015, previously published on October 2015
The European Court of Justice ("CJEU") has decided on a matter of great importance for applicants of pharmaceutical patents who have already obtained a supplementary protection certificate ("SPC") on the basis of a marketing authorization ("MA") or who intend to do so....


HTMLMetal-on-Metal Hip Implants Pose Potential Risk for Patients
Sara E. Coopwood; Waters & Kraus, LLP;
Legal Alert/Article
April 22, 2015, previously published on March 25, 2015
Metal-on-metal hip implants can lead to metal debris migrating from the device into the blood and surrounding tissue, according to the European Commission’s (EC’s) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). The EC described the potential health risk in...


HTMLNew England Executives Get an Inside Look at Israeli Innovation
Aaron R. Katz; Greenberg Traurig, LLP;
Legal Alert/Article
April 2, 2015, previously published on March 26, 2015
Israel is home to more than 750 medical device companies, 300 pharmaceutical/biotech companies, and 170 other life science or healthcare IT companies. David Dykeman, co-chair of Greenberg Traurig’s Life Science & Medical Technology Group, describes Israel as a “biomedical and...


HTMLIRS Ruling Permits Inclusion of “Friendly PCs” in Consolidated Federal Income Tax Returns
Theresa C. Carnegie, Ryan J. Cuthbertson, Carrie A. Roll, Jonathan R. Talansky; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
March 30, 2015, previously published on February 13, 2015
On December 19, 2014, the Internal Revenue Service (“IRS”) issued a private letter ruling (the “Ruling”) allowing corporations that manage physician practices through a so-called “friendly physician” arrangement to treat the physician practices as members of the...


HTMLSupreme Court Limits Antitrust Immunity for Certain State Agencies
Robert B. Craig, Aaron M. Herzig; Taft Stettinius & Hollister LLP;
Legal Alert/Article
March 25, 2015, previously published on March 2, 2015
Last week, the United States Supreme Court issued an opinion that will have a broad impact on how states regulate professions through agencies and licensing boards. In North Carolina State Board of Dental Examiners v. FTC, No. 13-534, 574 U.S. &under;&under; (2015), the court ruled that the...


HTMLU.S. Supreme Court Directs Lower Court to Rebalance Religious Freedom With Government Mandated Women’s Contraceptive Health Benefits for Religious Nonprofit Organizations
Dave C. Bromund; Taft Stettinius & Hollister LLP;
Legal Alert/Article
March 25, 2015, previously published on March 12, 2015
In its continuing consideration of the proper balance of religious freedom against government mandated women’s contraceptive health benefits, the U.S. Supreme Court vacated the 7th Circuit Court of Appeals’ 2014 decision against the University of Notre Dame’s religious objections...


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