Duane Morris LLP

Suite 2200 One Market, Spear Tower
San Francisco, California 94105-1104, United States

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FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA

On August 19, 2014, the U.S. Food and Drug Administration (FDA) issued in the Federal Register a request for comment and notice of public hearing on a variety of topics relating to its implementation of the Generic Drug User Fee…more
| Administrative Law, Intellectual Property, Science, Computers, & Technology

Congressional Approval of Mexico's Energy Reform Legislation

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,…more
| Constitutional Law, Energy & Utilities, Finance & Banking, International Law & Trade

"Ban the Box" Legislation Signed into Law in New Jersey

On August 11, 2014, New Jersey joined the growing number of jurisdictions banning the box on job applications that require job applicants to disclose criminal history information. This new legislation, the Opportunity to Compete…more
| Civil Rights, Labor & Employment Law

Back to School: Tax Benefits for Education

Students will soon be heading back to school, and with skyrocketing education costs, families are increasingly exploring ways to cut costs and save money. With that in mind, in this Alert, we summarize what many consider the…more
| Education, Taxation

Businesses Around the United States Being Targeted for Alleged Inaccessible Websites

While plaintiff's lawyers have been busy the past two years filing lawsuits around the United States alleging violations of the Americans with Disabilities Act (ADA) related to physical barriers—including a wave of class action…more
| Civil Rights, Commercial Law & Contracts, Science, Computers, & Technology

U.S. Department of Labor Proposes Rule to Collect Compensation Data from Federal Contractors

On August 6, 2014, the U.S. Department of Labor (DOL) announced a proposed rule that would require most federal contractors and subcontractors annually to submit Equal Pay Reports on employee compensation to the Office of…more
| Civil Rights, Labor & Employment Law, Government Contracting

ANDA Preparation (with an Eye toward Approval and Litigation) and the FDA Review

As a manufacturer of generic drug products, undoubtedly one of your goals is to prepare an Abbreviated New Drug Application (ANDA) that will pass regulatory scrutiny efficiently. Your ANDA submission is a culmination of time,…more
| Administrative Law, Commercial Law & Contracts, Health, Science, Computers, & Technology

FDA Declines to Issue Rulemaking for Section 505(b)(2) NDA Therapeutic Equivalence Ratings

On July 23, 2014, the Food and Drug Administration (FDA) issued its response to two citizen petitions submitted by AbbVie Inc. (AbbVie) and Auxilium Pharmaceuticals, Inc. (Auxilium) requesting that FDA initiate…more
| Administrative Law, Health, Science, Computers, & Technology

President Obama Issues Executive Order Aimed at Federal Contractors That Violate Labor Laws

The Fair Pay and Safe Workplaces Executive Order, signed by President Obama and released by the White House on July 31, 2014, is the latest in a series of recent directives on the employment obligations of federal contractors…more
| Alternative Dispute Resolution (ADR), Civil Rights, Labor & Employment Law, Government Contracting

Cook County Use Tax Declared Invalid by Illinois Appellate Court

Affirming the decision of the circuit court, the Illinois Appellate Court struck down the Cook County Non-Titled Personal Property Use Tax (imposed last year) as violating Illinois law…more
| Constitutional Law, Taxation

FDA Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA

The Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law on July 9, 2012, in an effort "to speed access to safe and effective generic drugs to the public and reduce costs to industry." In July 2014, the U.S…more
| Administrative Law, Health, Science, Computers, & Technology

"Ban the Box" in San Francisco: Posting, Reporting and Inquiry Rules for Applicants' and Employees' Criminal Histories Take Effect on August 13, 2014

Many employers ask job applicants to check a "box" on a job application to disclose criminal history information. As of August 13, 2014, San Francisco will "ban the box" for private and public employers. The City's Board of…more
| Civil Rights, Labor & Employment Law

NLRB Deems Micro-Unit an Appropriate Bargaining Unit in Retail Industry

The National Labor Relations Board (the "Board" or NLRB) recently issued a pair of decisions applying its Specialty Healthcare test to determine if petitioned-for units in two large department stores were appropriate for…more
| Labor & Employment Law

CMS Extends Moratoria for the Enrollment of New Home Health Agencies and Ambulance Suppliers and Providers

Over the past year, the Centers for Medicare & Medicaid Services (CMS) flexed its regulatory muscle to establish temporary moratoria on the enrollment of certain providers and suppliers under its recent authority pursuant to 42…more
| Health

California's Inside Sales Exemption May Be Lost Where Commissions Are Paid on a Monthly or Less Frequent Basis

A recent California Supreme Court decision significantly impacts pay practices for commissioned sales employees. On July 14, 2014, the state Supreme Court ruled in Peabody v. Time Warner Cable, Inc. that an employer may not…more
| Labor & Employment Law
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