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Document(s) published by this organization: 261


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HTMLFDA Issues Additional Guidances on Implementation of Drug Supply Chain Security Act
Duane Morris LLP;
Legal Alert/Article
March 3, 2015, previously published on February 25, 2015
The U.S. Food and Drug Administration (FDA) continues to publish draft guidance implementing the Drug Supply Chain Security Act (DSCSA). This Alert highlights key facts on three recent draft Guidance for Industry, which focus on: interoperable exchange of information, annual reporting by wholesale...

 

HTMLFDA Establishes the Office of Pharmaceutical Quality
Duane Morris LLP;
Legal Alert/Article
March 3, 2015, previously published on February 23, 2015
In a press conference earlier this year, Dr. Janet Woodcock, head of the U.S. Food and Drug Administration's (FDA) pharmaceutical division, stated that the FDA has been working on "establish[ing] consistent quality standards for all drugs, whether brand name or generic" over the past 10...

 

HTMLNew Jersey Supreme Court Adopts Affirmative Defense Under Federal Law to Claims of Supervisory Harassment Under State Law
Duane Morris LLP;
Legal Alert/Article
March 3, 2015, previously published on February 20, 2015
On February 11, 2015, the New Jersey Supreme Court decided Aguas v. New Jersey and established that New Jersey employers have an affirmative defense to claims of vicarious liability for supervisory harassment arising under the Law Against Discrimination (LAD).

 

HTMLDOL Issues FMLA Final Rule Recognizing Same-Sex Marriages and Establishing "Place of Celebration" as New Rule for Defining Spouse
Duane Morris LLP;
Legal Alert/Article
March 3, 2015, previously published on February 24, 2015
The United States Department of Labor (DOL) announced that on February 25, 2015, it will issue a Final Rule revising the regulations to the Family and Medical Leave Act (FMLA) to provide that the term "spouse" means a husband or wife and "refers to the other person with whom an...

 

HTMLUK Finance Bill 2015 -- Draft Clauses Published
Jenny Wheater; Duane Morris;
Legal Alert/Article
March 2, 2015, previously published on December 11, 2014
Draft clauses of the UK Finance Bill 2015 were published on 10 December 2014. They will now be the subject of consultation until 4 February 2015. This Alert provides more details on the most significant measures contained in the draft Finance Bill. It is not intended to be exhaustive but to provide...

 

HTMLFDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities
Duane Morris LLP;
Legal Alert/Article
February 26, 2015, previously published on December 9, 2014
On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include:

 

HTMLDelaware Court of Chancery Rules to Invalidate Two Post-Closing Obligations in the Audax Merger
Duane Morris LLP;
Legal Alert/Article
February 25, 2015, previously published on January 30, 2015
The recent volume of court decisions affecting the merger and acquisition landscape is outpaced only by the recent volume of merger and acquisition deals. These court decisions underscore the significance of properly structuring mergers and new platform and add-on acquisitions alike in order to...

 

HTMLCalifornia Federal Judge Invalidates Spinal Surgery Patents Due to Lack of Objective Boundaries
Duane Morris LLP;
Legal Alert/Article
February 25, 2015, previously published on December 1, 2014
On November 19, 2014, a federal district court in California invalidated claims in two spinal surgery patents, finding the claims indefinite under the U.S. Supreme Court's recent Nautilus standard. In Abdou v. Alphatec Spine, the Southern District of California granted summary judgment of...

 

HTMLNet Neutrality Revisited
William K. Keane; Duane Morris LLP;
Legal Alert/Article
February 18, 2015, previously published on February 6, 2015
The issue of "net neutrality" has occupied the Federal Communications Commission (FCC or "the Commission") for years. With the FCC poised to adopt a new regulatory regime for broadband providers at its meeting on February 26, FCC Chairman Tom Wheeler recently released the...

 

HTMLOFCCP to Update Sex Discrimination Guidelines
Duane Morris LLP;
Legal Alert/Article
February 18, 2015, previously published on February 5, 2015
On January 30, 2015, the Office of Federal Contract Compliance Programs (OFCCP) published a Notice of Proposed Rulemaking (NPRM) in the Federal Register to rescind and replace the OFCCP's Sex Discrimination Guidelines. These significant proposed regulations would rescind the current Sex...

 


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