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HTMLFDA Issues Draft Guidance on Data Integrity and Compliance with CGMP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The U.S. Food and Drug Administration (FDA) has recently published the draft guidance, Data Integrity and Compliance with CGMP, which comes after years of increased data integrity issues worldwide, including issues with oversight, or control, of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...

 

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...

 

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)...

 

HTMLEarn-Out Constructs: Getting the Matrix Right
Duane Morris LLP;
Legal Alert/Article
July 23, 2016, previously published on May 9, 2016
“The carrying power of a bridge is not the average strength of the pillars, but the strength of the weakest pillar.” - Zygmunt Bauman

 

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...

 

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...

 

HTMLU.S. Aims to Increase Transparency in Order to Combat Offshore Abuses in Wake of Release of Panama Papers
Duane Morris LLP;
Legal Alert/Article
July 23, 2016, previously published on May 6, 2016
On May 5, 2016, the Obama administration announced a series of proposals that will be sent to Congress designed to combat the disguising of international financial dealings through the use of anonymous financial corporations in the United States. The proposals are a signal to both domestic and...

 

HTMLU.S. Supreme Court Strengthens Protections for Criminal Defendants' Right to Counsel in the Federal Courts
Duane Morris LLP;
Legal Alert/Article
July 23, 2016, previously published on March 31, 2016
On March 30, 2016, the U.S. Supreme Court held that the Sixth Amendment to the United States Constitution guarantees a defendant’s right to access his or her funds that are untainted by any criminal conduct to pay for counsel. In Luis v. United States, 578 U.S.---(2016), the Supreme Court...

 

HTMLMust Employers Provide "Reasonable Accommodation" for Disability of a Worker's Family Member? California Court of Appeal Says, "Yes"
Duane Morris LLP;
Legal Alert/Article
July 23, 2016, previously published on April 7, 2016
This week, a California Court of Appeal concluded that an employer may have an obligation to provide “reasonable accommodation” for the disability of a worker’s family member. In Castro-Ramirez v. Dependable Highway Express, B261165 and B262524 (Los Angeles County Superior Court...

 


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