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Document(s) published by this organization: 144


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HTMLFTC'S New Consumer Data Security Guidance Offers Businesses Practical Tips
Kenneth R. Florin, Ieuan Jolly, James D. Taylor; Loeb & Loeb LLP;
Legal Alert/Article
July 31, 2015, previously published on July 2015
The Federal Trade Commission has issued new guidance on data security for companies that collect, store and use consumer information, gleaned from the more than 50 enforcement actions brought by the agency over the past decade. The guidance, "Start with Security: A Guide for Business,"...

 

HTMLFCC Order Clarifies Many Details in TCPA and FCC Rules Regarding Call and Text Message Marketing
Brian A. Nixon, Meredith J. Siller, Laura A. Wytsma; Loeb & Loeb LLP;
Legal Alert/Article
July 31, 2015, previously published on July 2015
In response to 20 petitions from various marketing companies, industry groups and advertisers, as well as a request for clarification from the National Association of Attorneys General, the Federal Communications Commission (FCC) issued a Declaratory Ruling and Order that clarifies issues relating...

 

Adobe PDFIntroductory Guide to Rev 973 v. Mouren-Laurens Et Al
Albert M. Cohen; Loeb & Loeb LLP;
Legal Alert/Article
July 27, 2015, previously published on July 2015
Rev 973, LLC v. John Mouren-Laurens, et al, 98-cv-10690 DSF (Ex), is pending in the United States District Court for the Central District of California. The case was filed in 1998 and involves claims that two sites in Compton, California, known as the Mouren-Laurens site (ML Site) and the Leach Oil...

 

HTMLIntern or Employee? Second Circuit Outlines Test to Determine Unpaid Interns' Status under Fair Labor Standards Act and New York Labor Law
Mark J. Goldberg, Michelle LaMar, Michael Z. Maizner; Loeb & Loeb LLP;
Legal Alert/Article
July 27, 2015, previously published on July 2015
The U.S. Court of Appeals for the Second Circuit July 2 handed down a significant decision in Glatt v. Fox Searchlight Pictures, Inc. in connection with a pair of lawsuits challenging the legality of unpaid internships under federal and New York law, establishing a new test for determining whether...

 

HTMLFDA Calls on Generic Drugmakers to Make Tablets, Capsules Physically Similar to Reference Drugs
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
July 15, 2015, previously published on June 2015
The regulator issued guidance on the size, shape and other physical attributes of generic tablets and capsules, recommending that the physical characteristics of generic drugs closely resemble those of their reference drugs.

 

HTMLEU Data Privacy Update: European Council Approves Agreement To Data Privacy Reform
Kenneth R. Florin, Ieuan Jolly, James D. Taylor; Loeb & Loeb LLP;
Legal Alert/Article
July 15, 2015, previously published on July 2015
European regulators took another step forward on the protracted and procedurally involved path to EU-wide data privacy reform earlier this month when the European Council (the organization of the individual member states) agreed upon a "common approach" to data privacy regulation that...

 

HTMLFDA Guidance Describes Implementation of the USP Salt Policy for Naming Prescription Drugs
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
July 15, 2015, previously published on June 2015
In a final guidance document, the regulator explains the USP naming and labeling policy for drug products containing salt as an active ingredient, and how the CDER is implementing it, in a bid to eliminate discrepancies between the established name and strength on labels.

 

HTMLAllergan Warned by FDA Over Unapproved Marketing of SERI Surgical Scaffold
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
July 14, 2015, previously published on June 2015
The regulator sent a letter to the company warning it for promoting the surgical mesh - which is approved to support and repair soft tissue and reinforce deficiencies - for breast surgery applications, which falls outside the scope of its approved indication.

 

HTMLFDA Provides Guidance on Assessing Potential Risks to Embryo/Fetal Development Posed by Drugs Used by Men
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
July 14, 2015, previously published on June 2015
The regulator’s guidance document contains recommendations for evaluating what the potential is for API exposure in males to adversely affect offspring development.

 

HTMLFDA Draft Guidance Explains Benefit-Risk Considerations for IDE Applications
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
July 14, 2015, previously published on June 2015
The regulator is clarifying the “principal factors” it will take into account with assessing the benefits and risks of IDE applications for human clinical study, and describing risk mitigation measures, in a bid to improve review process predictability and patient access to new devices.

 


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