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HTMLDrug Pumps Are Vulnerable to Hacking, FDA Warns
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
August 10, 2015, previously published on August 6, 2015
Last Friday, the Food and Drug Administration (FDA) issued a statement warning that certain drug infusion pumps that administer medication to patients are vulnerable to being hacked. The statement focused on the Symbiq Infusion System (Symbiq) manufactured by Hospira, Inc. Infusion pumps such as...

 

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 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...

 

HTMLDoes CPSC or FDA Have Jurisdiction Over Your Consumer Product?
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
August 5, 2015, previously published on July 28, 2015
As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the jurisdiction of the Consumer Product Safety Commission (CPSC).

 

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.”

 

HTMLThe Patchwork Solidifies: GMO Bill Moves Forward in the House
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
August 5, 2015, previously published on July 20, 2015
The proposed Federal regulation of GMOs is proceeding. Following the White House’s recent action on GMOs, Representative Pompeo’s “Safe and Accurate Food Labeling Act” (H.R. 1599) was passed by the House Agriculture Committee on July 14.

 

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...

 

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...

 


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