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HTMLFinal Rule on Section 1557 of the ACA Has Implications for Digital Health Industry
Stephen E. (Steve) Gillette, Alexis S. Gilroy, Kevin D. Lyles, Cristiana Spontoni, Soleil E. Teubner; Jones Day;
Legal Alert/Article
August 25, 2016, previously published on Augsut 2016
On May 18, 2016, the Department of Health and Human Services ("HHS") issued a final rule implementing Section 1557 of the Patient Protection and Affordable Care Act ("ACA"), which prohibits discrimination on the grounds of race, color, national origin, sex, age, or disability in...

 

HTMLFDA Proposes Regulatory Framework for Next Generation Sequencing-Based Tests
Edgar Asebey, Maureen Bennett, Christian B. Fulda, Colleen M. Heisey, Cristiana Spontoni; Jones Day;
Legal Alert/Article
August 11, 2016, previously published on August 2016
FDA recently released, as a part of President Obama's Precision Medicine Initiative, two draft guidance documents proposing what the Agency is calling a "flexible and streamlined approach" for regulating next generation sequencing ("NGS")-based tests. The first guidance...

 

HTMLFinancial Crimes Enforcement Network Releases FAQs on Diligence Procedures for Beneficial Owners of Accounts
William M. (Will) Atherton, Henry Klehm, Lisa M. Ledbetter, Ralph F. (Chip) MacDonald, C. Hunter Wiggins; Jones Day;
Legal Alert/Article
August 10, 2016, previously published on August 2016
On July 19, 2016, the U.S. Treasury's Financial Crimes Enforcement Network ("FinCEN"), issued its Frequently Asked Questions Regarding Customer Due Diligence Requirements for Financial Institutions ("FAQs").[1] The FAQs provide useful guidance for financial institutions'...

 

HTMLITC Issues Exclusion Order Despite Final PTAB Decision Finding Asserted Claims Unpatentable
Richard (Rich) Fieman, Blaney Harper, David M. (Dave) Maiorana; Jones Day;
Legal Alert/Article
August 5, 2016, previously published on July 2016
On July 20, 2016, the U.S. International Trade Commission ("ITC") issued a Notice in Certain Three-Dimensional Cinema Systems and Components Thereof, Inv. No. 337-TA-939, clarifying the effect of inter partes review ("IPR") proceedings on Section 337 investigations. The ITC...

 

HTMLFederal Circuit Decision Clarifies Application of On-Sale Bar to Third-Party Manufacturers and Suppliers
Gregory A. (Greg) Castanias, Anthony M. Insogna, Randy Kay, Greg Lanier, David M. (Dave) Maiorana; Jones Day;
Legal Alert/Article
August 3, 2016, previously published on July 2016
On July 11, 2016, in The Medicines Company v. Hospira, Inc., the Federal Circuit issued a rare unanimous en banc opinion addressing the circumstances under which a patentee's manufacturing and supply agreements with a third-party contractor could trigger the on-sale bar under 35 U.S.C. §...

 

HTMLKey Changes in TSCA Reform Legislation
Mary Beth Deemer, Kevin P. Holewinski, Jane Borthwick Story; Jones Day;
Legal Alert/Article
August 3, 2016, previously published on July 2016
After years of efforts aimed at updating the Toxic Substances Control Act[1] ("TSCA"), the Frank R. Lautenberg Chemical Safety for the 21st Century Act[2] ("Act") was signed into law on June 22, 2016. Chemical manufacturers and processors should begin to plan what internal...

 

Adobe PDFEEOC Issues Final Wellness Plan Regulations and Immediately Asserts Retroactive Effect
Fred W. Alvarez, Eric S. Dreiband, Michael J. Gray, Matthew W. (Matt) Lampe, Blake Pulliam; Jones Day;
Legal Alert/Article
August 3, 2016, previously published on July 2016
On May 16, 2016, the Equal Employment Opportunity Commission (“EEOC”) finalized highly anticipated regulations that purport to define the extent to which the Americans with Disabilities Act (“ADA”) and the Genetic Information Nondiscrimination Act (“GINA”) permit...

 

HTMLFDA Takes Steps to Streamline Individual Patient Expanded Access
Edgar Asebey, Maureen Bennett, Christian B. Fulda, Colleen M. Heisey, Cristiana Spontoni; Jones Day;
Legal Alert/Article
August 3, 2016, previously published on July 2016
On June 2, 2016, FDA announced the availability of three final guidance documents aimed at simplifying and clarifying expanded access for investigational drugs and assisting health care professionals, patients, and industry in navigating the expanded access process. In the FDA blog, FDA Voice, Dr....

 

HTMLSEC Publishes Final Rules Amending the Rules of Practice for Administrative Proceedings
Daniel Vincent Bradley, Harold K. Gordon, Henry Klehm, Joan E. McKown, David Ronald Woodcock; Jones Day;
Legal Alert/Article
August 3, 2016, previously published on July 2016
On July 13, 2016, the Securities and Exchange Commission ("SEC" or "Commission") voted to adopt amendments to the rules of practice that govern its Administrative Proceedings ("APs").[1] In a press release accompanying publication of the amended rules, SEC Chair Mary...

 

HTMLGeneral Contractor Not a "Seller" Entitled to Indemnity in Product Liability Case
Andrew D. (Andy) Ness, William R. (Will) Taylor, J. Laurens Wilkes; Jones Day;
Legal Alert/Article
August 3, 2016, previously published on July 2016
On June 17, 2016, the Texas Supreme Court held that a general contractor was not a "seller" under Chapter 82 of the Civil Practice and Remedies Code and, therefore, not entitled to indemnification from the manufacturer of an allegedly defective roof truss. See Centerpoint Builders GP v....

 


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