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HTMLFDA Warns ASCEND Therapeutics for Excluding from Zazzle Card Serious Risks Associated with EstroGel Use
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
August 5, 2015, previously published on July 2015
EstroGel is indicated to treat “moderate to severe vasomotor symptoms due to menopause” and “moderate to severe symptoms of vulvar and vaginal atrophy due to menopause,” and its use is associated with a several serious risks, the FDA letter states. Boxed warnings are...

 

HTMLFDA Finalizes Guidance on Analytical Procedures and Methods Validation
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
August 5, 2015, previously published on July 2015
The recommendations contained in the guidance document concern drug products covered in NDAs, ANDAs, BLAs and supplements to those applications, and complement the ICH guidance “Q2(R1) Validation of Analytical Procedures: Text and Methodology.”

 

HTMLFDA Issues Guidance for Dispensers to Explain Compliance Policy on Product Tracing Requirements and Notes Limited Exemptions
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
August 5, 2015, previously published on July 2015
Section 202 of the DSCSA, which was signed into law in 2013 and added new sections to the FDCA, laid out new product tracing definitions and requirements. Beginning in 2015, trading partners must provide subsequent purchasers with product tracing information when it comes to transactions that...

 

HTMLFDA Provides Guidance on Orphan Drug Meetings With OOPD
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
August 5, 2015, previously published on July 2015
The guidance document is aimed at assisting stakeholders with requesting, preparing, scheduling, conducting and documenting meetings with the OOPD to address issues related to orphan drug designation requests, humanitarian use device (HUD) designation requests, rare pediatric disease designation...

 

HTMLFood Court Report: Consumer Claims Targeting Trans Fat In Instant Noodles Case Survive Motion To Dismiss
Eric P. Gotting; Keller and Heckman LLP;
Legal Alert/Article
August 4, 2015, previously published on July 29, 2015
Last month we wrote about FDA's determination that trans fat will no longer be generally recognized as safe ("GRAS") and that the agency's decision could open the door for consumers wishing to attack food products containing trans fat.1 Perhaps in a sign of things to come, the "Food...

 

HTMLEmployer in the Restaurant Industry Beware: Employees have a Private Right of Action for Violation of the Tennessee "Tip Statute"
Christen C. Blackburn, J. Gregory Grisham; Leitner, Williams, Dooley & Napolitan, PLLC;
Legal Alert/Article
July 31, 2015, previously published on Summer 2015
The Tennessee Court of Appeals recently determined that tipped employees may file a lawsuit against their employer for violations of Tennessee Code Annotated Section 50-2-107 (¿Section 107¿), commonly known as the ¿Tip Statute.¿ Kim Hardy v. Tournament Players Club, Inc. d/b/a ¿TPC Southwind¿ et...

 

HTMLFDA Issues Warning Letter to Corporate Sponsor of Clinical Trial
Linda D. Bentley; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
July 30, 2015, previously published on July 21, 2015
The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company with offices in France and New Jersey, regarding the company’s...

 

HTMLGMOs in the Hotseat: White House to Overhaul Regulatory Framework on Biotechnology
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
July 15, 2015, previously published on July 10, 2015
Last week, the White House waded into the GMO regulatory fray with the Office of Science and Technology Policy’s (OSTP) announcement of a major overhaul of GMO regulation.

 

HTMLFDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
July 3, 2015, previously published on June 30, 2015
On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until November 1, 2015 (Compliance Policy). As we previously discussed, pursuant...

 

HTMLSupreme Court Upholds Affordable Care Act Rule Authorizing Health Subsidies in States with Federal Exchanges
Robert P. Charrow; Greenberg Traurig, LLP;
Legal Alert/Article
June 29, 2015, previously published on June 25, 2015
Today, in King v. Burwell, the Supreme Court in a 6-3 decision authored by the Chief Justice upheld the IRS Regulation (“the Regulation”) that provided subsidies under the Affordable Care Act (ACA) to individuals in States with only federally established - as opposed to State...

 


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