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HTMLFDA Issues Draft Guidance on Determination of Reference Product Exclusivity for Biologics
Colleen Heisey, Mark Mansour, Christopher M. Mikson; Jones Day;
Legal Alert/Article
August 12, 2014, previously published on August 2014
On August 4, the U.S. Food & Drug Administration ("FDA") issued a draft guidance titled "Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act." The draft guidance is intended to assist biological product sponsors and applicants in...

 

HTMLD.C. Circuit Holds that CFIUS Must Provide Due Process Before Prohibiting a Transaction
Giovanna M. Cinelli, Chad O. Dorr, Noel J. Francisco, Bevin M.B. Newman, Kenneth J. Nunnenkamp; Jones Day;
Legal Alert/Article
August 5, 2014, previously published on July 2014
The U.S. Court of Appeals for the D.C. Circuit has issued a landmark opinion granting due process rights to parties whose transactions have been blocked or suspended by the President of the United States following a national security review and investigation by the Committee on Foreign Investment...

 

HTMLLegislators and Groups Urge FDA to Require Sex-Specific Data, Labeling in New Action Plan
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
August 5, 2014, previously published on July 2014
Members of Congress and interest groups are pressuring FDA to promote sex-specific clinical research and product labeling, as the Agency develops an action plan to address deficiencies in the way industry collects, analyzes, and communicates demographic data.

 

HTMLFDA Accepts First Application for Biosimilar Product
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
August 5, 2014, previously published on July 2014
In a significant step for generic biologic products, FDA accepted for review the first application for a biosimilar product. If approved, it could be the first biosimilar product to enter the U.S. market under the nearly five-year-old Biologics Price Competition and Innovation Act...

 

HTMLFDA Using Big Data Methods to Discover Drug Risks, Provide Access to Recall Information
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
August 5, 2014, previously published on July 2014
Through recently deployed initiatives, FDA is taking advantage of new data systems to gather and assess drug risk data and promote easier public access to adverse event and recall information. The two projects, Mini-Sentinel and open FDA, offer greater efficiencies than existing methods, such as...

 

HTMLFederal Communications Commission Requests Comments on Effectiveness of Cybersecurity Recommendations
Richard J. Johnson, Bruce A. Olcott, Mauricio F. Paez, Preston N. Thomas; Jones Day;
Legal Alert/Article
August 1, 2014, previously published on July 2014
The Federal Communications Commission ("FCC") is seeking industry and public comment on whether it should take further steps to ensure that the U.S. communications industry is sufficiently prepared for cybersecurity threats.

 

HTMLNew Tax Treaty Between Mexico and United Arab Emirates Enters into Force
Rodrigo Gómez, Karl L. Kellar, Andrés Lieja, Luis Ignacio Martel, Luis Rodrigo Salinas; Jones Day;
Legal Alert/Article
July 24, 2014, previously published on July 2014
The Mexico-United Arab Emirates tax treaty, signed on May 20, 2012 (the "Treaty"), entered into force on July 9, 2014 after its publication in the Mexican Official Gazette. Pursuant to Article 28, the Treaty will be applicable on January 1, 2015. The Treaty results from Mexico's...

 

HTMLRecent Decision in Lance Armstrong False Claims Act Case Raises New Timeliness Arguments
Peter F. Garvin, Meghan E. Greenfield, J. Andrew Jackson, Grant H. Willis, Alexander M. Yabroff; Jones Day;
Legal Alert/Article
July 24, 2014, previously published on July 2014
For several years now, litigants have wrestled with three questions: (i) does the Wartime Suspension of Limitations Act ("WLSA") apply to civil False Claims Act ("FCA") actions, (ii) do the 2009 Fraud Enforcement and Recovery Act ("FERA") amendments to the FCA apply to...

 

HTMLIn re: Kellogg Brown & Root, Inc., et al.: D.C. Circuit Grants Petition for Mandamus and Protects Attorney-Client Privilege of Internal Investigation in False Claims Act Case
J. Andrew Jackson, Lindsey Lonergan, Rebekah N. Plowman, Stephen G. Sozio; Jones Day;
Legal Alert/Article
July 24, 2014, previously published on July 2014
In March 2014, we issued an Alert summarizing a decision issued by the U.S. District Court for the District of Columbia in United States ex rel. Barko v. Halliburton Co., et al. The District Court granted a relator's motion to compel and ordered defendants to produce documents reflecting the...

 

HTMLPayers, Pension Plans, Pharmacies Ask FDA Not to Give Unique Names to Biosimilars
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
Earlier this month, a group of 32 companies and organizations, including health insurers, pharmacies, labor unions, and pension plans, urged FDA not to require distinct names for biosimilar products, explaining that such a policy would undermine the potential cost savings generated by such generic...

 


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