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|FDA Draft Guidance Outlines Appropriate Labeling for Injectable Drug Doses|
Scott S. Liebman; Loeb & Loeb LLP;
November 10, 2015, previously published on Scott LiebmanThe FDA released draft guidance on how to label injectable drugs for their appropriate doses, offering a new definition of single- and multiple-dose containers and replacing the term “single-use” with “single-patient-use.” Sponsors are being tasked with updating their labels...
|Is Your Website ADA-Compliant? Does It Need to Be?|
Ed Chansky, Robert S. Fine, Erica Okerberg; Greenberg Traurig, LLP;
November 10, 2015, previously published on November 5, 2015Title 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...
|CDRH Looks to Keep Pace with New Technology, Bolster Patient Safety with 2016 Regulatory Science Priorities|
Scott S. Liebman; Loeb & Loeb LLP;
November 10, 2015, previously published on Ocotber 2015The 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...
|Supreme Court to Review Federal Circuit Test for Willful Patent Infringement|
Paula K. Colbath, Kathleen M. Gersh; Loeb & Loeb LLP;
October 26, 2015, previously published on October 2015The 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.
|CJEU Decides on Calculation of SPC Term|
Christian B. Fulda, Tetiana Kharkovets; Jones Day;
October 23, 2015, previously published on October 2015The 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....
|Metal-on-Metal Hip Implants Pose Potential Risk for Patients|
Sara E. Coopwood; Waters & Kraus, LLP;
April 22, 2015, previously published on March 25, 2015Metal-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...
|New England Executives Get an Inside Look at Israeli Innovation|
Aaron R. Katz; Greenberg Traurig, LLP;
April 2, 2015, previously published on March 26, 2015Israel 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...
|IRS 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.;
March 30, 2015, previously published on February 13, 2015On 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...
|U.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;
March 25, 2015, previously published on March 12, 2015In 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...
|Supreme Court Limits Antitrust Immunity for Certain State Agencies|
Robert B. Craig, Aaron M. Herzig; Taft Stettinius & Hollister LLP;
March 25, 2015, previously published on March 2, 2015Last 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...