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HTMLFDA Issues Final Hatch-Waxman Regulations
Duane Morris LLP;
Legal Alert/Article
December 9, 2016, previously published on October 7, 2016
The U.S. Food and Drug Administration (FDA) on October 6, 2016, finally issued a Final Rule to implement provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), entitled “Abbreviated New Drug Applications and 505(b)(2) Applications.” A preliminary...

 

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...

 

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.

 

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...

 

HTMLChina Enacts Preferential Income Tax Toward Non-listed Companies Who Carry Out Equity Incentive Plans to Promote Development of Science and Technology Enterprises
Duane Morris LLP;
Legal Alert/Article
December 9, 2016, previously published on October 13, 2016
In order to promote China’s science and technology innovation, as well as industrial upgrading, on September 22, 2016, Ministry of Finance (“MOF”) and the State Administration of Taxation (“SAT”) jointly issued the “Notice on Improving the Income Tax Policies...

 

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...

 

HTMLRecent Independent Contractor Developments Impact All New York City Employers
Duane Morris LLP;
Legal Alert/Article
December 9, 2016, previously published on November 17, 2016
Recent legislation by the New York City Council and a recent decision by New York’s highest court impact all New York City employers who engage independent contractors.

 

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.

 

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...

 


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