Mondaq USA: All Topics
Jones Day
EMA is proposing changes to current guidance on first-in-human clinical trials with the aim of improving strategies to identify and mitigate risks to trial participants.
Jones Day
EMA has published a final report on the experience gained during its pilot project on adaptive pathways, a product development concept for medicines that address patients' unmet medical needs.
Jones Day
The European Commission has published a revised version of its Guidelines on Qualification and Classification of Stand-Alone Software ("MEDDEV 2.1/6"), which replaces the earlier 2012 version.
Jones Day
EMA has released new good manufacturing practice guidance aimed at ensuring the integrity of data generated in the process of testing, manufacturing, packaging, distributing, and monitoring medicines.
Sullivan & Worcester LLP
U.S. Bankruptcy Judge Stuart Bernstein recently approved SunEdison's proposed sale of $144 million of solar and wind assets to NRG Energy.
Brown Smith Wallace
U.S. Generally Accepted Accounting Principles (GAAP) are a set of rules and procedures that accountants typically follow to record and summarize business transactions.
Brown Smith Wallace
The Center for Audit Quality — an autonomous, nonprofit public policy organization composed of accounting professionals — has compiled a checklist of possible questions for audit committees...
Fox Rothschild LLP
In Rosenberg v. DVI Receivables XVII, LLC, the United States Court of Appeals for the Third Circuit held that Section 303(i) of the United States Bankruptcy Code does not preempt state law claims.
Fox Rothschild LLP
The Court of Chancery recently denied a fee award to a litigation funding firm in the decision of Judy v. Preferred Communication Systems, Inc., C.A. No. 4662-VCL (Del. Ch. Sept. 19, 2016).
Reed Smith
When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation...
Fox Rothschild LLP
California's legislature has passed two new statutes that increase the protections for employees arbitrating workplace disputes.
Foley & Lardner
The district court found that the ‘915 patent was entitled to the benefit of the filing date of the ‘072 application.
Fox Rothschild LLP
The State Department announced that it will begin accepting applications for the FY 2018 Diversity Immigrant Visa Program—commonly called the diversity visa (DV) lottery—beginning Tuesday, October 4, 2016.
Jones Day
改正連邦民事訴訟規則が2015年12月1日に施行されました。この改正は、実質的な争点の解決を促し、広範かつ過度な証拠開示（discovery）を限定する
Thompson Coburn LLP
The allocation of risk via representations and warranties and the accompanying indemnification obligations is a primary source of contention in almost every private merger and acquisition transaction.
Carlton Fields
The Ninth Circuit recently reversed a trial court for compelling arbitration without issuing an order that made "the necessary factual findings as to the parties' communications,"
Goldin Peiser & Peiser, LLP
Employers of workers facing significant barriers to employment are urged to apply for the Work Opportunity Tax Credit (WOTC) enacted by the Protecting Americans from Tax Hikes (PATH) Act.
Seyfarth Shaw LLP
For a multitude of reasons, the stakes are exceedingly high for employers in the upcoming Presidential election.
Akin Gump Strauss Hauer & Feld LLP
On September 22, 2016, FERC issued a Notice of Inquiry (NOI) seeking comment on whether and, if so, how FERC might modify or enhance its methods for identifying and assessing market power.
Morrison & Foerster LLP
"Enough already!" Reading between the lines, this is what a seemingly exasperated California Supreme Court appears to be saying in its latest California Environmental Quality Act ("CEQA") decision.
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On October 1, 2015, the US Department of State will begin accepting requests to register for the 2017 Diversity Immigrant Visa Program (DV-2017), also known as the Green Card Lottery.
Ropes & Gray LLP
As a result of these changes, millions of workers will lose their current FLSA-exempt status on December 1, 2016.
Smith Gambrell & Russell LLP
Processing of H-1B extensions with the United States Citizenship and Immigration Service (USCIS) continue to be extraordinary slow, at both the Vermont and California Service Centers.
Kaye Scholer LLP
Cisco predicts that by the year 2020, there will be 50 billion devices connected to the internet, and some of those will be connected to other IoT devices as well.
Fox Rothschild LLP
Below are highlights from the most recent "check-in with Charlie" (May 9, 2016), reflecting his analysis of current trends and future projections for the various immigrant preference categories.
Fox Rothschild LLP
In our continuing series of reports, Charles ("Charlie") Oppenheim, Chief of the Visa Control and Reporting Division, U.S. Department of State, shares his most recent analysis of current trends and future projections for the various immigrant preference categories with AILA (the American Immigration Lawyers' Association).
Troutman Sanders LLP
On August 25 and 26, 2016, the CAISO filed Readiness Certifications with the Commission for Puget Sound Energy, Inc. and Arizona Public Service Company, respectively.
Morrison & Foerster LLP
The views of the UK financial services regulator on the risks and issues inherent in cloud usage are likely to be welcomed by regulated financial services firms with UK operations.
Troutman Sanders LLP
On August 31, 2016, FERC conditionally approved APS request to amend its market-based rate tariff to facilitate APS' participation in the western EIM administered by the CAISO.
Dentons
Effective October 1, 2016, green cards will become more readily available for most people immigrating to the United States on employment-based (EB) immigrant visa categories.
