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HTMLFDA Issues Guidance on Self-Identification of Generic Drug Facilities
Duane Morris LLP;
Legal Alert/Article
December 9, 2016, previously published on October 6, 2016
The U.S. Food and Drug Administration (FDA) has published a guidance entitled “Self-Identification of Generic Drug Facilities, Sites, and Organizations,” which is intended to assist generic drug companies in complying with the self-identification requirement of the Generic Drug User Fee...

 

HTMLTrichloroethylene is Now Formally Listed as a “Known Human Carcinogen”
Seth V.D.H. Cooley; Duane Morris LLP;
Legal Alert/Article
December 9, 2016, previously published on November 2016
After many years of being listed as a possible or probable human carcinogen, the widely used-and widely released to the environment-solvent trichloroethylene (TCE) has now been listed by the National Toxicology Program (NTP) of the U.S. Department of Health and Human Services as a “known...

 

HTMLElection Day Is Almost Here - Employers May Want to Review Their Obligations Regarding Employee Leave Rights
Duane Morris LLP;
Legal Alert/Article
December 9, 2016, previously published on November 2, 2016
With the U.S. election season upon us, employers should be aware of state laws governing whether or not they are obligated to allow employees time off from work, paid or unpaid, in order to vote in the upcoming election. Voting leave time varies by employee classification and state law.

 

HTMLFDA Form 483 Inspectional Observations Are Not Findings of Wrongdoing
Duane Morris LLP;
Legal Alert/Article
December 9, 2016, previously published on October 24, 2016
Since shortly after the U.S. Food and Drug Administration (“FDA”) began publishing FDA Form 483 inspectional observations of Section 503B outsourcing facilities, many State Boards of Pharmacy have inappropriately relied upon the FDA’s findings as a basis to pursue outsourcing...

 

HTMLPotential Perils of Using Dropbox and Similar Service Providers
Duane Morris LLP;
Legal Alert/Article
December 9, 2016, previously published on November 15, 2016
You may have heard of Dropbox, SecuriSync, Citrix ShareFile, Rackspace and similar electronic file sharing and storage service providers. You may even use one of these service providers. But are they safe? This is an important conversation to have from both individual and business perspectives.

 

HTMLFifty-Six Hours of Paid Sick Leave for Employees of Federal Contractors and Their Subcontractors
Duane Morris LLP;
Legal Alert/Article
December 9, 2016, previously published on November 1, 2016
Paid sick leave laws have been a growing trend in city, county and state legislatures across the country over the last few years. Now, the federal government has joined the trend. Beginning January 1, 2017, and depending on the federal procurements involved, federal contractors and subcontractors...

 

HTMLChina Issues Several Implementing Rules to Reform Its Foreign Investment Administrative System
Duane Morris LLP;
Legal Alert/Article
December 9, 2016, previously published on October 14, 2016
On 3 September 2016, China’s Standing Committee of the National People’s Congress approved the Resolution of Amending Four Laws, including the Law of the People’s Republic of China on Wholly Foreign-Owned Enterprises, which provides that the establishment and changes of the...

 

HTMLPortions of Fair Pay and Safe Workplaces Regulations and Guidance Preliminarily Enjoined
Duane Morris LLP;
Legal Alert/Article
December 9, 2016, previously published on October 26, 2016
On October 24, 2016, the mandatory disclosure and arbitration provisions of the Fair Pay and Safe Workplaces (“FPSW”) Regulations and Guidance were preliminarily enjoined by the United States District Court for the Eastern District of Texas in Associated Builders and Contractors of...

 

HTMLWhat the Recent Cyberattack Means and Ways Businesses Can Protect Themselves
Duane Morris LLP;
Legal Alert/Article
December 9, 2016, previously published on October 24, 2016
The unprecedented cyberattack on October 21, 2016, which crippled many of the Internet’s most widely trafficked sites, should be a wakeup call for businesses about the potential for hackers to weaponize common Internet-enabled devices and cripple businesses.

 

HTMLRecent Ninth Circuit Court of Appeals Decision Renders Entz-White Void: Default Interest Can Be Collected by Secured Creditor in Connection with a Cure Under Chapter 11 Plan
Duane Morris LLP;
Legal Alert/Article
December 9, 2016, previously published on November 9, 2016
The Ninth Circuit Court of Appeals recently issued a decision in Pacifica L 51, LLC v. New Investments, Inc. (In re New Investments, Inc.) (16 C.D.O.S. 11723, Nov. 4, 2016), which held that a secured creditor can collect default interest in connection with a cure under a chapter 11 plan, thereby...

 


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