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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...

 

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The U.S. Food and Drug Administration (FDA) continues to publish draft guidance implementing the Drug Supply Chain Security Act (DSCSA). This Alert highlights key facts on three recent draft Guidance for Industry, which focus on: interoperable exchange of information, annual reporting by wholesale...

 

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...

 

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:

 

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...

 

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...

 

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...

 

HTMLWhat's New for Tax Year 2014 (When Filing in 2015)
Duane Morris LLP;
Legal Alert/Article
February 18, 2015, previously published on February 12, 2015
The following are select tax topics affecting individuals and businesses for tax year 2014. Several issues of significance to individuals and businesses for 2013 remain relevant for 2014 and are noted below. The impact of select new topics below, such as individual and business impacts of the...

 

HTMLOFAC General License No. 5 Allows Certain Activities Prohibited by Executive Order 13685 in Order to Wind Down Operations in Crimea Region of Ukraine
Duane Morris LLP;
Legal Alert/Article
February 17, 2015, previously published on January 5, 2015
On December 19, 2014, President Obama signed Executive Order 13685, which further limits commercial transactions and blocks the property and interest in property of certain persons associated with the Russian occupation of the Crimea region of Ukraine. The Order announced additional steps that...

 

HTMLSummary of EU Changes to the Rule on VAT Place of Supply of Services
Duane Morris LLP;
Legal Alert/Article
February 17, 2015, previously published on January 12, 2015
From 1 January 2015, VAT payable on the supply of digital services (telecommunications, broadcasting and electronic) will be determined by the location of the consumer in all circumstances. This means that VAT on digital services supplied will be paid for in the consumer's country and charged at...

 


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