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Document(s) published by this organization: 142


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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...

 

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 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.

 

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.

 

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.

 

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.

 

HTMLGlatt v. Fox Searchlight Pictures, Inc.
Loeb Loeb LLP;
Legal Alert/Article
July 14, 2015, previously published on July 2, 2015
Second Circuit vacates district court's ruling that unpaid interns who worked on film Black Swan and at Fox's corporate offices should have been classified as employees and thus entitled to minimum-wage and overtime pay, remanding for further consideration of whether intern or employer is...

 

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.

 

HTML16 Casa Duse, LLC v. Merkin
Loeb Loeb LLP;
Legal Alert/Article
July 14, 2015, previously published on June 29, 2015
In matter of first impression, Second Circuit affirms ruling that director does not own copyright interest in film that he directed, because his creative contributions were inseparable from and integrated into film.

 


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