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HTMLFDA Issues Draft Guidance for Regulation of LDTs
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
October 10, 2014, previously published on October 6, 2014
On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance is the next step in FDA’s implementation of...

 

HTMLERISA’s “Overlapping Fields of Fire” Preempt Wisconsin’s Family and Medical Leave Act
Theodore T. Eidukas; Foley & Lardner LLP;
Legal Alert/Article
October 10, 2014, previously published on October 6, 2014
Wisconsin’s Family and Medical Leave Act (“WFMLA”), requires that employers allow employees six weeks of unpaid leave following “[t]he birth of an employee’s natural child,” and that employers allow an employee to substitute “paid or unpaid leave of any...

 

HTMLFederal Circuit Upholds Inequitable Conduct Post Therasense For Withheld Information
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
October 7, 2014, previously published on October 2, 2014
In American Calcar, Inc. v. American Honda Motor Co., the Federal Circuit upheld the district court’s finding that three Calcar patents are unenforceable due to inequitable conduct. Both courts reached this decision of inequitable conduct post Therasense despite the fact that the validity of...

 

HTMLNHTSA's September Scrutiny
Christopher H. Grigorian; Foley & Lardner LLP;
Legal Alert/Article
October 7, 2014, previously published on October 2, 2014
September was a difficult month for NHTSA. During one week alone, a New York Times article blasted NHTSA for failing to investigate a number of defects that later resulted in injuries and fatalities and, ultimately, recalls; the House Energy & Commerce Committee issued a scathing report...

 

HTMLSEC Reverses Course and Awards Dodd-Frank Whistleblower $400,000
Bryan B. House, Pamela L. Johnston, Courtney Worcester; Foley & Lardner LLP;
Legal Alert/Article
October 7, 2014, previously published on October 3, 2014
On July 31, 2014, the SEC awarded $400,000 to a whistleblower who had reported internally before providing information to the SEC. The award was unique because the SEC’s Claims Review Staff had denied the whistleblower’s claim on the grounds that the information provided had not been...

 

HTMLOnly 28 Days Left to Submit Comments Regarding the CFPB’s Proposed Modifications to Home Mortgage Disclosure (Regulation C)
Yesenia Garcia Perez; Foley & Lardner LLP;
Legal Alert/Article
October 7, 2014, previously published on Octobier 2, 2014
The Consumer Financial Protection Bureau (“CFPB”) has published for public comment, a proposed rule amending Regulation C to implement amendments to the Home Mortgage Disclosure Act (HMDA). The HMDA requires certain financial institutions to collect and report information in connection...

 

HTML7th Cir. Upholds Springfield's Panhandling Ordinance, Using a Historic Twist
Eric G. Pearson; Foley & Lardner LLP;
Legal Alert/Article
October 3, 2014, previously published on September 29, 2014
It can’t have happened often (if at all) that a retired Justice would decide a new case based on his reading of an opinion in which he dissented.

 

HTMLU.S. Regulations Can Raise Risks for Reshoring and Next-Generation Manufacturing
Gregory Husisian; Foley & Lardner LLP;
Legal Alert/Article
October 3, 2014, previously published on October 1, 2014
More than a third of United States businesses are either bringing back or considering bringing back manufacturing activity to the U.S. through “reshoring.” Although one would think that bringing production back to the U.S. would minimize the impact of U.S. regulations of international...

 

HTMLUpdate on Insider Trading in Mutual Fund Shares
Peter D. Fetzer, Terry D. Nelson; Foley & Lardner LLP;
Legal Alert/Article
October 3, 2014, previously published on September 30, 2014
As we reported in 2013, the U.S. Court of Appeals for the Seventh Circuit left open the possibility that insider trading prohibitions may apply to trading in mutual fund shares, and remanded the case to the district court to determine whether the insider’s alleged conduct properly fit under...

 

HTMLCost of Proposed User Fees by Registered Investment Advisers Further Discussed
Peter D. Fetzer, Terry D. Nelson; Foley & Lardner LLP;
Legal Alert/Article
October 3, 2014, previously published on September 30, 2014
As most of our readers are aware, there has been a proposal advocated by various parties, including certain members of Congress, that a funding source to pay for the increase of SEC examinations over registered investment advisers be provided by imposing user fees on registered advisers. You...

 


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