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On October 27, 2015, the U.S. Food and Drug Administration (FDA) published notice of two draft guidance documents in the Federal Register [1] : “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug...

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted “to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed in the United States...

Duane Morris LLP named Bender's Immigration Bulletin Editorial Board Member Valentine Brown as Pro Bono Partner : "Duane Morris LLP is pleased to announce new leadership of its firmwide Pro Bono Program . Valentine A. Brown as Pro Bono Partner...

On August 6, 2014, the Mexican Congress finally approved secondary legislation (the "Legislation") providing for the implementation of the historic constitutional energy reforms in Mexico that were approved on December 20, 2013, and which were...

In what is likely to be a harbinger of changes to status quo retail electricity markets, services and grid planning, the New York State Public Service Commission (New York PSC) adopted a new policy framework that would significantly influence the development...

By statute, New York state utilities are required to offer net metering of electricity to generators of certain renewable energy resources, depending on the size of the project. Net metering means that, to the extent that there is surplus energy that...

A recent decision by the U.S. Court of Appeals for the District of Columbia Circuit rejected certain portions of an environmental analysis conducted by the Federal Energy Regulatory Commission (FERC or "Commission"). This turn of events is likely...

On December 3, 2012, the U.S. Court of Appeals for the Ninth Circuit in Celador International, Inc. v. American Broadcasting Companies, Inc., et al. [ enhanced version available to lexis.com subscribers ] upheld an interesting jury verdict, resulting...

In QBE Insurance Corporation v. Jorda Enterprises (Free Download), Judge Alan Gold of the U.S. District Court for the Southern District of Florida granted summary judgment to HVAC subcontractor Jorda Enterprises Inc., who was insured by The Hartford Insurance...

The Food Safety and Modernization Act (FSMA) provides that the U.S. Food and Drug Administration (FDA) assess fees for certain domestic and foreign facility reinspections, failure to comply with recall orders, and importer reinspections. On August 1,...

On March 12, 2012, the U.S. Department of Health and Human Services (HHS) released the long-anticipated Final Rule and Interim Final Rules (the "Rules") on the Patient Protection and Affordable Care Act's (ACA) state health insurance exchanges...

On June 6, 2012, in Windsor v. United States , U.S. District Judge Barbara Jones in the Southern District of New York granted summary judgment to Edith Windsor and created a precedent that is likely to positively affect same-sex married couples for years...

With the U.S. Supreme Court decision ratifying President Obama's Patient Protection and Affordable Care Act (the "Affordable Care Act"), the implementation and development of accountable care organizations (ACOs) continued in full force...

Representing the latest decision involving Medicaid providers' attempts to judicially combat cuts to Medicaid reimbursement, on February 22, 2012, the U.S. Supreme Court handed down a five-to-four decision in Douglas v. Independent Living Center of...

More than two years after the passage of New Jersey's Compassionate Use Medical Marijuana Act ("Act"), patients are now able to register and receive state-issued identification cards to obtain prescriptions for medical marijuana. Formal...