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Document(s) published by this organization: 151


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HTMLFDA Issues Draft Guidance on Data Integrity and Compliance with CGMP
Duane Morris LLP;
Legal Alert/Article
July 28, 2016, previously published on May 3, 2016
The U.S. Food and Drug Administration (FDA) has recently published the draft guidance, Data Integrity and Compliance with CGMP, which comes after years of increased data integrity issues worldwide, including issues with oversight, or control, of paper records and inadequacies of audit trails. It is...

 

HTMLImplementation Day Occurs Under the Joint Comprehensive Plan of Action: Highlights of the Sanctions Lifted on Iran
Duane Morris LLP;
Legal Alert/Article
July 28, 2016, previously published on January 19, 2016
Implementation Day under the Joint Comprehensive Plan of Action (JCPOA) was on January 16, 2016. It marked the official verification by the International Atomic Energy Agency that Iran implemented its nuclear-related obligations under its agreements with the United States, the European Union and...

 

HTMLFERC Grants Complaints Based on Affiliate Abuse
Dennis J. Hough; Duane Morris LLP;
Legal Alert/Article
July 28, 2016, previously published on May 2016
In a pair of almost-identical complaints brought by a coalition of wholesale power generators led by the Electric Power Supply Association (Complainants), the Federal Energy Regulatory Commission’s (Commission) affiliate abuse rules were recently put to the test. Electric Power Supply...

 

HTMLFDA Implements Expedited Review of ANDA Submissions for "Sole-source" Drug Products
Duane Morris LLP;
Legal Alert/Article
July 23, 2016, previously published on March 31, 2016
The U.S. Food and Drug Administration (FDA) recently updated its Manual of Policies and Procedures (MAPP) 5240.3 on Prioritization of the Review of Original ANDAs, Amendments and Supplements to Revision 2, adding a new category of expedited review of abbreviated new drug application (ANDA)...

 

HTMLNew Paid Leave Laws Taking Effect in San Francisco and Across California
Duane Morris LLP;
Legal Alert/Article
July 23, 2016, previously published on May 11, 2016
California is once again at the forefront of increasing employee benefits-likely bringing joy and relief to employees with new babies but concern to many employers. Just weeks after increasing California’s minimum wage to $15 per hour (See our April 18, 2016 Duane Morris Alert), the Golden...

 

HTMLU.S. Bankruptcy Court in California Issues Decision on Enforceability of Prepetition Waivers of the Automatic Stay
Duane Morris LLP;
Legal Alert/Article
July 23, 2016, previously published on May 4, 2016
Adding to the unsettled body of case law on the enforceability of prepetition waivers of the automatic stay, on April 27, 2016, the U.S. Bankruptcy Court for the Central District of California issued a memorandum decision finding that cause existed to grant relief from stay where a chapter 11...

 

HTMLDepartment of Labor's "Persuader" Rule Greatly Expands Employers' Reporting Requirements
Duane Morris LLP;
Legal Alert/Article
July 23, 2016, previously published on March 28, 2016
On March 23, 2016, the U.S. Department of Labor (DOL) issued its final rule regarding “persuader” activity, nearly five years after its initial proposed rule and despite vigorous opposition from the American Bar Association, 13 state attorneys general, numerous trade associations and...

 

HTMLCalifornia's Amended FEHA Regulations Take Effect on April 1, 2016
Duane Morris LLP;
Legal Alert/Article
July 23, 2016, previously published on March 30, 2016
Beginning April 1, 2016, amended anti-discrimination, harassment and retaliation regulations take effect for all companies with five or more employees (full- or part-time) if any of those employees work in California. Now may be a good time for all employers to consider whether their equal...

 

HTMLU.S. Department of Justice Announces New FCPA Pilot Program Designed to Encourage Companies to Self-Report Bribery
Duane Morris LLP;
Legal Alert/Article
July 23, 2016, previously published on April 7, 2016
On April 5, 2016, the U.S. Department of Justice (DOJ), Fraud Section, announced a series of bold steps to encourage companies to come forward and disclose their wrongdoing in the anti-corruption arena. While this likely ensures that the wave of Foreign Corrupt Practices Act (FCPA) cases and...

 

HTMLPennsylvania Contractors May Not Discriminate Based on Sexual Orientation or Gender Identity
Duane Morris LLP;
Legal Alert/Article
July 23, 2016, previously published on April 12, 2016
Citing the need to end discrimination based on sexual orientation, gender identity or gender expression in the executive branch of state government, on April 7, 2016, Pennsylvania Governor Tom Wolf signed Executive Order No. 2016-05, which prohibits private organizations that contract with or are...

 


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