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Document(s) published by this organization: 130


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HTMLFDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
Duane Morris LLP;
Legal Alert/Article
July 8, 2014, previously published on June 20, 2014
The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, which provides answers to questions from public comments received on the draft Guidance for Industry on ANDAs:...

 

HTMLD.C. Circuit Ruling Has Potential Implications for Natural Gas Pipeline and LNG Projects Under FERC Environmental Review
Duane Morris LLP;
Legal Alert/Article
July 8, 2014, previously published on June 24, 2014
A recent decision by the U.S. Court of Appeals for the District of Columbia Circuit rejected certain portions of an environmental analysis conducted by the Federal Energy Regulatory Commission (FERC or "Commission"). This turn of events is likely to cause anyone with, or planning to have,...

 

HTMLNew Jersey Prepayment Law Does Not Apply to Individual Guarantors of a Commercial Loan
Duane Morris LLP;
Legal Alert/Article
July 8, 2014, previously published on June 27, 2014
The New Jersey Superior Court, in Lopresti v. Wells Fargo Bank, N.A., determined that the New Jersey Prepayment Law, N.J.S.A. § 46:10B-1, does not apply to individual guarantors who had guaranteed a commercial loan. There, the lender made a commercial loan to a corporate borrower. The...

 

HTMLFDA Issues Draft Guidance for Identification and Notification of Suspect Products
Duane Morris LLP;
Legal Alert/Article
July 8, 2014, previously published on June 24, 2014
As discussed in our April 11, 2014 Alert, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." Recently, the U.S. Food and Drug...

 

HTMLSecond Circuit Upholds "Neither Admit Nor Deny"
Duane Morris LLP;
Legal Alert/Article
July 8, 2014, previously published on June 16, 2014
On June 4, 2014, the United States Circuit Court for the Second Circuit endorsed the Securities and Exchange Commission's practice of settling enforcement cases on a "neither admit nor deny" basis. In its order issued in SEC v. Citigroup Global Markets, Inc., the Second Circuit vacated...

 

HTMLThe Success Checklist: What mHealth Investors and Entrepreneurs Should Kno
Lisa W. Clark, C. Mitchell Goldman; Duane Morris LLP;
Legal Alert/Article
July 8, 2014, previously published on June 18, 2014
A healthcare start-up developer has an intriguing concept for an app or a software solution. It may be an app tied to a sensor that is designed to transmit a diabetic's blood glucose levels to her physician, or an app that has a proprietary algorithm that analyzes a heart patient's water retention...

 

HTMLGuidance for Illinois Employers on Amendments to the Human Rights Act and a Reminder to All Employers Regarding Obligations to Women Affected by Pregnancy and Childbirth
Duane Morris LLP;
Legal Alert/Article
July 8, 2014, previously published on June 17, 2014
On May 28, 2014, the Illinois legislature passed amendments to the Illinois Human Rights Act that expand employment protections for employees and applicants related to pregnancy, childbirth and related conditions. The additional protections, which are awaiting Illinois Governor Pat Quinn's expected...

 

HTMLHighlights of Mexico's Energy Reform Legislation
Duane Morris LLP;
Legal Alert/Article
June 6, 2014, previously published on May 23, 2014
Following the historic constitutional energy reforms the Mexican Congress passed in December 2013—which we reported on in a prior Duane Morris Alert—Mexican President Enrique Peña Nieto submitted on April 30, 2014, for approval of the Mexican Congress, the secondary legislation...

 

HTMLInch-by-Inch: FDA's New Biosimilars Guidance Inches the Industry Closer to Clinical Testing Clarity
Duane Morris LLP;
Legal Alert/Article
May 23, 2014, previously published on May 15, 2014
For those under cloudy skies for two years, even a small break in the clouds would seem like a bright sunshiny day. The U.S. Food and Drug Administration's (FDA) newest draft guidance on demonstrating biosimilarity largely reiterates FDA's past guidance on the subject, but offers more insight on...

 

HTMLFederal Judge Strikes Down Pennsylvania Same-Sex Marriage Ban, Resulting in Significant Impact on Employee Benefit Plans
Duane Morris LLP;
Legal Alert/Article
May 23, 2014, previously published on May 21, 2014
On May 20, 2014, a federal judge in the case of Whitewood v. Wolf struck down both Pennsylvania's ban on marriage for same-sex couples and its prohibition against recognition of same-sex marriages legally entered into in other jurisdictions on the grounds that such laws violate both the Due...

 


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