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HTMLFDA Releases Draft Guidance on Bioequivalence Requirements for ANDA Applicants
Duane Morris LLP;
Legal Alert/Article
December 11, 2013, previously published on December 6, 2013
On December 4, 2013, the U.S. Food and Drug Administration (FDA) issued a draft guidance on demonstrating bioequivalence for drugs submitted under an Abbreviated New Drug Application (ANDA). Entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, the new...

 

HTMLUK Finance Bill: Key Points from the Autumn Statement
Duane Morris LLP;
Legal Alert/Article
December 6, 2013, previously published on December 5, 2013
UK Chancellor of the Exchequer George Osborne gave his Autumn Statement speech to the House of Commons on 5th December 2013, which was followed by some limited press releases and draft legislation. This Alert provides an overview of some of the key announcements.

 

HTMLU.S. Supreme Court Issues Significant Forum-Selection Decision
Duane Morris LLP;
Legal Alert/Article
December 6, 2013, previously published on December 4, 2013
There has been confusion in the courts over the years regarding the appropriate mechanism to enforce forum-selection clauses, which are now routinely included in many commercial and personal contracts. Such clauses typically require any dispute between contracting parties to be resolved in the...

 

HTMLCompounding Pharmacies Now Subject to Federal Oversight
Duane Morris LLP;
Legal Alert/Article
December 4, 2013, previously published on December 2, 2013
On November 27, 2013, President Obama signed into law the Drug Quality and Security Act. Title I of this law—entitled the Compounding Quality Act (the "CQA")—allows the federal Food and Drug Administration (FDA) to oversee drug compounding in human health. The CQA does not...

 

HTMLThe Development of Global Capital Standards for IAIGs and G-SIIs: Notes from IAIS Meeting on November 13, 2013
Duane Morris LLP;
Legal Alert/Article
November 29, 2013, previously published on November 25, 2013
In July 2013, the Financial Stability Board (FSB) designated nine insurance groups as global systemically important insurers (G-SIIs). Simultaneously, the International Association of Insurance Supervisors (IAIS) released its framework of policy measures for G-SIIs, which included the concept of...

 

HTMLFACT Act Promises Transparency in Bankruptcy Trust Claims and Payments for Asbestos Exposure
Duane Morris LLP;
Legal Alert/Article
November 22, 2013, previously published on November 18, 2013
Asbestos defendants are one step closer to greater transparency regarding the often illusive bankruptcy trust claims and payments. On Wednesday, November 13, 2013, the U.S. House of Representatives passed H.R. 982, the Furthering Asbestos Claim Transparency (FACT) Act by a 221-199 vote. FACT would...

 

HTMLUpdates from USCIS: Parole in Place, E-Verify and December Visa News
Duane Morris LLP;
Legal Alert/Article
November 22, 2013, previously published on November 19, 2013
The U.S. Citizenship and Immigration Services (USCIS) has released a policy memorandum addressing the parole of spouses, children and parents of active duty members of the U.S. Armed Forces, members of the Selected Reserve of the Ready Reserve (including the National Guard) or veterans who...

 

HTMLFDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do
Duane Morris LLP;
Legal Alert/Article
November 15, 2013, previously published on November 12, 2013
On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved Abbreviated New Drug Applications (ANDAs) to add warnings, precautions, adverse...

 

HTMLSEC Targets Investment Adviser Community
Duane Morris LLP;
Legal Alert/Article
November 15, 2013, previously published on November 12, 2013
The Enforcement Division of the Securities and Exchange Commission (SEC) and its Office of Compliance Inspections and Examinations (OCIE) are focusing their examination and disciplinary efforts on the investment adviser community.

 

HTMLNew Jersey Voters Approve Minimum Wage Increase
Duane Morris LLP;
Legal Alert/Article
November 11, 2013, previously published on November 8, 2013
On November 5, 2013, New Jersey residents voted to approve an amendment to the New Jersey Constitution that will result in a $1.00 increase in the state's minimum wage rate. As of January 1, 2014, New Jersey's minimum wage rate will increase from $7.25 to $8.25 per hour. The constitutional...

 


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