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HTMLFTC Safe Harbor Actions
Ieuan Jolly; Loeb & Loeb LLP;
Legal Alert/Article
August 25, 2015, previously published on August 2015
While the U.S.-EU “Safe Harbor” Framework for transferring data into the United States is hardly new — it was approved 15 years ago — the Federal Trade Commission has recently focused its enforcement efforts on companies that inaccurately represent their certification under...

 

HTMLA Recent FCC Order May Require Financial Institutions and Healthcare Providers to Put Robocalls to Wireless Phone Numbers on Hold
Mitchell F. Brecher, Debra McGuire Mercer; Greenberg Traurig, LLP;
Legal Alert/Article
August 14, 2015, previously published on August 13, 2015
A recent Federal Communications Commission (FCC) Order issued July 10, 2015, (Robocall Order) clarifies several provisions in the Telephone Consumer Protection Act (TCPA) (47 U.S.C. § 227) and the FCC’s implementing regulations (47 C.F.R. § 64.1200). Those laws provide that an...

 

HTMLMerchants Beware: You Could Be on the Hook for the Next Data Breach
Richard W. Cline, James J. Giszczak, Dominic A. Paluzzi, Adam C. Smith; McDonald Hopkins LLC;
Legal Alert/Article
August 12, 2015, previously published on August 12, 2015
Starting Oct. 1, 2015, credit card companies and banks will enforce new terms in their acceptance guidelines, commonly known as liability shift provisions. These provisions are based on the rollout of Europay, MasterCard and Visa (EMV) technology. If there is an incident of fraud after October 1,...

 

HTMLFDA Provides Guidance on Orphan Drug Meetings With OOPD
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
August 5, 2015, previously published on July 2015
The guidance document is aimed at assisting stakeholders with requesting, preparing, scheduling, conducting and documenting meetings with the OOPD to address issues related to orphan drug designation requests, humanitarian use device (HUD) designation requests, rare pediatric disease designation...

 

HTMLFDA Issues Guidance for Dispensers to Explain Compliance Policy on Product Tracing Requirements and Notes Limited Exemptions
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
August 5, 2015, previously published on July 2015
Section 202 of the DSCSA, which was signed into law in 2013 and added new sections to the FDCA, laid out new product tracing definitions and requirements. Beginning in 2015, trading partners must provide subsequent purchasers with product tracing information when it comes to transactions that...

 

HTMLFDA Warns ASCEND Therapeutics for Excluding from Zazzle Card Serious Risks Associated with EstroGel Use
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
August 5, 2015, previously published on July 2015
EstroGel is indicated to treat “moderate to severe vasomotor symptoms due to menopause” and “moderate to severe symptoms of vulvar and vaginal atrophy due to menopause,” and its use is associated with a several serious risks, the FDA letter states. Boxed warnings are...

 

HTMLFDA Finalizes Guidance on Analytical Procedures and Methods Validation
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
August 5, 2015, previously published on July 2015
The recommendations contained in the guidance document concern drug products covered in NDAs, ANDAs, BLAs and supplements to those applications, and complement the ICH guidance “Q2(R1) Validation of Analytical Procedures: Text and Methodology.”

 

HTMLAre Your Website Terms of Use Enforceable?
Ed Chansky, Erica Okerberg; Greenberg Traurig, LLP;
Legal Alert/Article
July 16, 2015, previously published on July 16, 2015
What does it take to create a binding contract online? This question has vexed courts, consumers, and e-commerce companies since the dawn of the Internet.

 

HTMLFCC Modifies Cost Recovery Rules for Medical Device Tests and Proposes Greater Access to MedRadio Bands for Testing
Russell H. Fox, Stephen J. Wang; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
July 15, 2015, previously published on July 13, 2015
On July 6, 2015, the Federal Communications Commission (“FCC”) adopted a Memorandum Opinion and Order modifying its rules covering Experimental Radio Service (“ERS”) licenses, which permit research and testing of radio equipment. Notably, the FCC clarified that some cost...

 

HTMLRecent Antimicrobial Registration Provides for Intermediate Master Batches
John B. Dubeck, Michael T. Novak, David G. Sarvadi; Keller and Heckman LLP;
Legal Alert/Article
July 15, 2015, previously published on July 9, 2015
On May 15, 2015, EPA’s Office of Pesticide Programs (OPP) (Antimicrobials Division) conditionally approved Nanosilva LLC’s registration of “NSPW-L30SS” as a materials preservative with an explicit clearance allowing the manufacture of intermediate master batches. EPA Reg....

 


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