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HTMLFDA's Final Guidance on the Circumstances That Constitute Interference with a Drug Inspection
Carolyn A. Alenci, Frederick R. Ball; Duane Morris LLP;
Legal Alert/Article
January 19, 2015, previously published on December 23, 2014
The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances that would constitute interference with a drug inspection under the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012.

 

HTMLHow Immediate is “Prompt” in a Contract? New Delaware Supreme Court Justice Vaughn Finds that It Depends
Christopher M. Winter; Duane Morris LLP;
Legal Alert/Article
January 6, 2015, previously published on November 18, 2014
What does the term “prompt” mean in a contract? Well, it depends, according to Judge James T. Vaughn Jr., who was recently confirmed to the Delaware Supreme Court. In an opinion issued last week from his prior post in the Superior Court (Complex Commercial Division), Justice Vaughn...

 

HTMLDangerous Technology Requires Old-Fashioned Diplomatic Solution
Eric J. Sinrod; Duane Morris LLP;
Legal Alert/Article
January 2, 2015, previously published on November 18, 2014
In these blogs over the years, we have covered many of the fantastic advantages of high technology. Unfortunately, though, tech also can be used for unsavory purposes, to put it mildly. Indeed, with tech, mankind has developed new and different ways to kill other people. As an example, fairly...

 

HTMLThe Irony of Defamation Lawsuits - Construction Edition
Stanley A. Martin; Duane Morris LLP;
Legal Alert/Article
January 2, 2015, previously published on November 14, 2014
There is a certain irony in any defamation lawsuit, which is a public request for redress arising from a statement the claimant says should not have been made public. Now we have the construction version. Company A sues Company B, claiming statements of B about the quality of A’s work defamed...

 

HTMLOIG 2015 Work Plan - Home Health
Ari J. Markenson; Duane Morris LLP;
Legal Alert/Article
January 2, 2015, previously published on November 17, 2014
Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will...

 

HTMLFDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act
Carolyn A. Alenci, Frederick R. Ball; Duane Morris LLP;
Legal Alert/Article
December 10, 2014, previously published on November 17, 2014
Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution...

 

HTMLResponding to Subpoena for Medical Records May Create Liability for Healthcare Providers Under State Law Negligence Claims
Seth A. Goldberg, Philip H. Lebowitz; Duane Morris LLP;
Legal Alert/Article
December 10, 2014, previously published on November 14, 2014
Healthcare providers receiving a subpoena for patient medical records may want to think twice before complying with the subpoena and producing the records. A recent Connecticut case, Byrne v. Avery Center for Obstetrics and Gynecology, P.C. ("Byrne"), arose when the defendant gynecology...

 

HTMLNew Jersey Establishes Complex Business Litigation Program
James J. "J." Ferrelli; Duane Morris LLP;
Legal Alert/Article
December 10, 2014, previously published on November 19, 2014
The Supreme Court of New Jersey has announced the establishment of a Complex Business Litigation Program, effective January 1, 2015, with designated judges in each county assigned to provide individualized case management to complex business, commercial and construction cases meeting the program...

 

HTMLThe Singapore-India Connection: A Robust Past and a Compelling Future
Saionton Basu; Duane Morris;
Legal Alert/Article
November 19, 2014, previously published on October 21, 2014
In determining the optimum gateway for investing into India, reliance on industry data may be the most prudent opening gambit. Data released by India's Department of Industrial Policy & Promotion peg Mauritius and Singapore as the top two destinations through which foreign direct investment and...

 

HTMLWhen the “Discovery Rule” is Irrelevant
Adam L. Gill, Jeffrey L. Hamera; Duane Morris LLP;
Legal Alert/Article
November 18, 2014, previously published on September 29, 2014
Can the statute of limitations for a claim expire even before a project owner knows that it has a claim? This is a very real possibility if one is not careful in drafting contracts. Courts generally recognize that sophisticated business entities should be permitted to forfeit rights in contracts,...

 


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