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HTMLFDA to Undergo Changes As Recommendations for Re-Alignment are Released Amid "Unparalleled Challenges" Posed By Product Complexity and Globalization
Loeb Loeb LLP;
Legal Alert/Article
January 23, 2015, previously published on October 2014
More than a year after its creation, the Program Alignment Group (PAG) issued final recommendations on how to realign the FDA, releasing six distinct "Action Plans" in a bid to improve the agency’s structure and regulation.

 

HTMLFDA Puts Final Touches on Inspection Guidance to Provide More Clarity and Respond to Industry Concerns, While Maintaining Strong Stance on Its Photography Authority
Loeb Loeb LLP;
Legal Alert/Article
January 23, 2015, previously published on October 2014
In finalizing a policy aimed at ensuring companies aren’t able to hide problems during inspections, the agency provided the industry with additional details regarding facility inspections in a bid to reduce confusion, adding descriptive material and preserving robust rules about photography.

 

HTMLFDA Attempts to Increase Security of Mobile Devices in Midst of Growing Threat of Cyberattacks with Guidance Focusing on Security-By-Design, While Some Say Focus Should Be on Data
Loeb Loeb LLP;
Legal Alert/Article
January 23, 2015, previously published on October 2014
As the regulator attempts to play catch-up with the fast-evolving world of connected devices by issuing guidance, critics fear the regulations fail to fully address the complexity of cyber threats.

 

HTMLFda Issues Final Guidance on Discerning Device Recalls from Market Withdrawals Related to Medical Device Enhancements in Apparent Bid to Appease Industry Concern Over Draft Being Overly Broad, Lacking in Term Definitions
Loeb Loeb LLP;
Legal Alert/Article
January 23, 2015, previously published on October 2014
The regulator put out the final guidance document to ensure companies are able to clearly distinguish a recall from a market withdrawal after the draft version sparked concern and confusion throughout the industry.

 

HTMLIndiana Attorney General Proposes Strengthening Online Privacy, Data Storage and Security Breach Laws
Kenneth Florin, Ieuan Jolly, James Taylor; Loeb Loeb LLP;
Legal Alert/Article
January 19, 2015, previously published on January 2015
Indiana has become the latest state to propose more stringent privacy laws, potentially creating new compliance challenges for companies that do business in many different states.

 

HTMLNot Your Everyday Grind: Seventh Circuit Panel Reverses Class Certification Denial in Keurig Competitor Case
Loeb Loeb LLP;
Legal Alert/Article
December 23, 2014, previously published on October 30, 2014
In a decision reflecting what could be interpreted as receptivity to consumer class actions - or at least a favorable disposition toward class certification requests - the Seventh Circuit recently issued a decision reversing both the lower court's denial of class certification and its issuance of...

 

HTML2 Supreme Court Cases May Rethink Trademark Law
Douglas Masters; Loeb Loeb LLP;
Legal Alert/Article
December 23, 2014, previously published on Decmeber 11, 2014
Last week the U.S. Supreme Court reviewed two cases addressing how courts determine trademark infringement—both with implications for how the issue of consumer perception impacts the ability of companies to protect and enforce their trademarks. Oral arguments suggested that the rulings will...

 

HTMLAccountability Program Releases Compliance Warning on Enhanced Notice for Online Native Advertising
Loeb Loeb LLP;
Legal Alert/Article
December 23, 2014, previously published on December 2014
The Online Interest-Based Advertising Accountability Program is serious about compliance with the transparency and consumer control provisions of the Digital Advertising Association's Self-Regulatory Principles for Online Behavioral Advertising. This week, the Program issued a new compliance...

 

HTMLThe Regulators Are Coming! The Regulators Are Coming!
Jerry S. Phillips; Loeb & Loeb LLP;
Legal Alert/Article
December 10, 2014, previously published on November 2014
Regulators, in-house lawyers and compliance officers told a serious cautionary tale at the recent Practicing Law Institute Broker-Dealer Regulation and Enforcement seminar. Representatives of the Securities and Exchange Commission, FINRA, the Department of Justice and state securities regulators,...

 

Adobe PDF"The New Promotional Rules: “There Are No New Promotional Rules”
Scott S. Liebman; Loeb Loeb LLP;
Legal Alert/Article
December 5, 2014, previously published on November 2014
There is resounding evidence that physicians and patients rely on the Internet—including social medial platforms—to research and communicate health information. FDA, however, has been slow to adapt even though the potential benefits to patients are great. In line with requirements set...

 


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