On November 22, 2011, the U.S. Food and Drug Administration (FDA) published a Warning Letter to Mylan, Inc. Found here, the October 13, 2011 Warning Letter cites Mylan for “significant […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-12-02 14:23:092025-12-09 15:54:46FDA Issues Warning to Mylan Over CGMP Violations
On November 4, 2011, two New Jersey attorneys, Goldie Sommer and Edward Engelhart, were charged with conspiring to violate and violating the Bank Secrecy Acts (“BSA”) by “structuring” attorney trust […]
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The (VCSP) provides employers partial relief from past federal employment tax obligations related to workers voluntarily reclassified from independent contractors to employees. In its announcement of the program, the IRS […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-11-30 08:52:552025-12-09 15:54:41IRS’s Voluntary Classification Settlement Program Ignores the Penalty Free Relief Available to Employers under Section 530 of the Revenue Act of 1978
On November 4, 2011, Hill Dermaceuticals, Inc. (Hill), a Florida-based drug manufacturer, sued the U.S. Food and Drug Administration (FDA). Hill brought suit in connection with the FDAs recent approval […]
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On November 3, 2011, the U.S. Court of Appeals for the Tenth Circuit affirmed the findings of the District of Wyoming, granting the dismissal of the lawsuit filed by Cody […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-11-28 11:13:422026-01-05 14:48:3910th Circuit Dismisses Claims against FDA for Failure to Exhaust Administrative Remedies
On November 9, 2011, the U.S. Food and Drug Administration (FDA) published “SOP: Decision Authority for Additional or Changed Data Needs for Premarket Submissions.” The document sets forth limitations to […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-11-28 08:05:392025-12-09 15:54:08FDA Issues SOP Aimed at Standardizing Data Requirements for Premarket Submissions
On November 18, 2011, the U.S. Food and Drug Administration (FDA) announced its decision to revoke the approval of the breast cancer indication for Avastin. Because Avastin will still be […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-11-28 08:04:062025-12-09 15:54:02FDA Withdraws Approval of Breast Cancer Indication from Avastin Label
On November 10, 2011, the U.S. Food and Drug Administration (FDA) announced its approval of the first blood product derived from cord blood indicated for treatment as a stem cell therapy. HEMACORD, the hematopoietic progenitor cell-cord (HPC-C) blood product, is intended for use in HPC transplant procedures for individuals affected with various blood disorders.
On November 4, 2011, a Bill was introduced before the U.S. House of Representatives that proposes to restrict the definition of “new dietary ingredient” (NDI) under the Federal Food, Drug and Cosmetic Act (FDCA). Introduced by Representative Dan Burton, the “Dietary Supplement Protection Act of 2011” seeks to alter the current definition of NDI by changing the applicable dates for which a dietary ingredient must have previously been marketed in the United States.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-11-23 14:11:182026-01-06 09:02:10Bill Aims to Increase Number of Grandfathered Dietary Ingredients
On November 18, 2011, the World Trade Organization (WTO) published its report on the ongoing Country of Origin Labeling (COOL) dispute. Implemented in 2008 as part of the Farm Bill, U.S. manufacturers began requiring country-of-origin to be designated in labeling of meats and other goods regulated by the U.S. Department of Agriculture (USDA). Found here, the WTO report details the complaints raised by Canada and Mexico, including the contention that the labeling requirements constitute Technical Barriers to Trade (TBT), in violation of international treaties between the countries.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-11-23 14:08:532014-11-10 18:16:00WTO Finds Country of Origin Labeling a Technical Barrier to Trade
FDA Issues Warning to Mylan Over CGMP Violations
On November 22, 2011, the U.S. Food and Drug Administration (FDA) published a Warning Letter to Mylan, Inc. Found here, the October 13, 2011 Warning Letter cites Mylan for “significant […]
Two Attorneys Arrested and Charged with Structuring Transactions to Avoid Bank Secrecy Act Reporting Requirements
On November 4, 2011, two New Jersey attorneys, Goldie Sommer and Edward Engelhart, were charged with conspiring to violate and violating the Bank Secrecy Acts (“BSA”) by “structuring” attorney trust […]
IRS’s Voluntary Classification Settlement Program Ignores the Penalty Free Relief Available to Employers under Section 530 of the Revenue Act of 1978
The (VCSP) provides employers partial relief from past federal employment tax obligations related to workers voluntarily reclassified from independent contractors to employees. In its announcement of the program, the IRS […]
Hill Dermaceuticals Sues FDA Following Approval of Generic Derma-Smoothe
On November 4, 2011, Hill Dermaceuticals, Inc. (Hill), a Florida-based drug manufacturer, sued the U.S. Food and Drug Administration (FDA). Hill brought suit in connection with the FDAs recent approval […]
10th Circuit Dismisses Claims against FDA for Failure to Exhaust Administrative Remedies
On November 3, 2011, the U.S. Court of Appeals for the Tenth Circuit affirmed the findings of the District of Wyoming, granting the dismissal of the lawsuit filed by Cody […]
FDA Issues SOP Aimed at Standardizing Data Requirements for Premarket Submissions
On November 9, 2011, the U.S. Food and Drug Administration (FDA) published “SOP: Decision Authority for Additional or Changed Data Needs for Premarket Submissions.” The document sets forth limitations to […]
FDA Withdraws Approval of Breast Cancer Indication from Avastin Label
On November 18, 2011, the U.S. Food and Drug Administration (FDA) announced its decision to revoke the approval of the breast cancer indication for Avastin. Because Avastin will still be […]
FDA Approves First Blood Product for Stem Cell Therapy
On November 10, 2011, the U.S. Food and Drug Administration (FDA) announced its approval of the first blood product derived from cord blood indicated for treatment as a stem cell therapy. HEMACORD, the hematopoietic progenitor cell-cord (HPC-C) blood product, is intended for use in HPC transplant procedures for individuals affected with various blood disorders.
Bill Aims to Increase Number of Grandfathered Dietary Ingredients
On November 4, 2011, a Bill was introduced before the U.S. House of Representatives that proposes to restrict the definition of “new dietary ingredient” (NDI) under the Federal Food, Drug and Cosmetic Act (FDCA). Introduced by Representative Dan Burton, the “Dietary Supplement Protection Act of 2011” seeks to alter the current definition of NDI by changing the applicable dates for which a dietary ingredient must have previously been marketed in the United States.
WTO Finds Country of Origin Labeling a Technical Barrier to Trade
On November 18, 2011, the World Trade Organization (WTO) published its report on the ongoing Country of Origin Labeling (COOL) dispute. Implemented in 2008 as part of the Farm Bill, U.S. manufacturers began requiring country-of-origin to be designated in labeling of meats and other goods regulated by the U.S. Department of Agriculture (USDA). Found here, the WTO report details the complaints raised by Canada and Mexico, including the contention that the labeling requirements constitute Technical Barriers to Trade (TBT), in violation of international treaties between the countries.