On October 28, 2010, a federal grand jury in Miami indicted two executives with Luxembourg based Cargolux Airlines on charges of conspiring to fix surcharge rates on air cargo shipments […]
The FDA and FTC have recently issued another joint warning letter, this time to Telledent, LLC, a dietary supplement manufacturer in Miami, Florida. In the letter, FDA and FTC cite Telledent for unlawful promotion involving treatment for Herpes, Epilepsy, […]
Speaking before the American Institute of Certified Public Accountants (AICPA) on October 26, 2010, Commissioner Douglas H. Schulman announced the Internal Revenue Service’s (IRS) goals of “a sound, fair and efficient tax administration” and “improved compliance.” In implementing these goals, the IRS has adopted the “Return Preparer Initiative”, which Commissioner Schulman described as part of “an evolutionary change of getting smarter and working smarter.”
Back on September 24, 2010, the Internal Revenue Service released the final Schedule UTP and associated guidance regarding the disclosure of uncertain tax positions (UTP) by corporations. At the same […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-10-25 15:24:132025-12-09 13:39:03Requesting a Private Letter Ruling on Uncertain Tax Positions? You may have to Wait for Guidance Instead
The U.S. Court of International Trade has ruled this month that Customs and Border Protection (CBP) unfairly targeted U.S. shrimp importers with its enhanced bonding requirement (EBR). The ruling stems […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-10-25 15:22:172026-01-06 10:01:16CBP loses court case on enhanced bonding requirements for shrimp importers.
On September 24, 2010, the Internal Revenue Service released the final version of Schedule UTP regarding “uncertain tax positions.” The new Schedule finalized the requirement that specified categories of corporate […]
The U.S. Food and Drug Administration (FDA) has announced that it will hold a two-day public hearing on November 2-3, 2010 for the purpose of gathering “input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).”
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-10-20 07:54:242025-12-09 13:38:37FDA Announces Public Meeting on Approval Pathways for Biosimilars
On October 14, 2010, the Department of Justice announced it had reached a settlement with CVS Pharmacy, Inc. (“CVS”) for unlawful sales of pseudoephedrine, a key product in the manufacture […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-10-15 10:14:102026-01-07 15:16:57CVS To Pay Largest Civil Penalty Ever Under The Controlled Substances Act for Unlawful Sales of Pseudoephedrine
Yesterday we reported the comments of Eric Blumberg, FDA Deputy Chief Counsel for Litigation, who said that the FDA will increase misdemeanor criminal prosecutions for pharmaceutical executives whose companies are […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-10-15 10:10:592025-12-09 13:38:29More News on the Coming Wave of FDA Enforcement Actions
The FDA should target for misdemeanor criminal prosecution the executives of pharmaceutical companies which promote unauthorized uses of their medicines. This is the latest message from Eric Blumberg, Deputy Chief […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-10-14 14:49:432014-11-10 18:23:18FDA Message to Pharma: Misdemeanor Criminal Charges can Result from Promoting Off-Label Drug Uses
Cargolux Executives Indicted In Rate Fixing Conspiracy
On October 28, 2010, a federal grand jury in Miami indicted two executives with Luxembourg based Cargolux Airlines on charges of conspiring to fix surcharge rates on air cargo shipments […]
FTC maintains momentum in dietary supplement regulation
The FDA and FTC have recently issued another joint warning letter, this time to Telledent, LLC, a dietary supplement manufacturer in Miami, Florida. In the letter, FDA and FTC cite Telledent for unlawful promotion involving treatment for Herpes, Epilepsy, […]
IRS Commissioner Introduces the Return Preparer Initiative
Speaking before the American Institute of Certified Public Accountants (AICPA) on October 26, 2010, Commissioner Douglas H. Schulman announced the Internal Revenue Service’s (IRS) goals of “a sound, fair and efficient tax administration” and “improved compliance.” In implementing these goals, the IRS has adopted the “Return Preparer Initiative”, which Commissioner Schulman described as part of “an evolutionary change of getting smarter and working smarter.”
Requesting a Private Letter Ruling on Uncertain Tax Positions? You may have to Wait for Guidance Instead
Back on September 24, 2010, the Internal Revenue Service released the final Schedule UTP and associated guidance regarding the disclosure of uncertain tax positions (UTP) by corporations. At the same […]
CBP loses court case on enhanced bonding requirements for shrimp importers.
The U.S. Court of International Trade has ruled this month that Customs and Border Protection (CBP) unfairly targeted U.S. shrimp importers with its enhanced bonding requirement (EBR). The ruling stems […]
New Schedule UTP Finalizes Guidance on Uncertain Tax Positions and FASB Interpretation No. 48
On September 24, 2010, the Internal Revenue Service released the final version of Schedule UTP regarding “uncertain tax positions.” The new Schedule finalized the requirement that specified categories of corporate […]
FDA Announces Public Meeting on Approval Pathways for Biosimilars
The U.S. Food and Drug Administration (FDA) has announced that it will hold a two-day public hearing on November 2-3, 2010 for the purpose of gathering “input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).”
CVS To Pay Largest Civil Penalty Ever Under The Controlled Substances Act for Unlawful Sales of Pseudoephedrine
On October 14, 2010, the Department of Justice announced it had reached a settlement with CVS Pharmacy, Inc. (“CVS”) for unlawful sales of pseudoephedrine, a key product in the manufacture […]
More News on the Coming Wave of FDA Enforcement Actions
Yesterday we reported the comments of Eric Blumberg, FDA Deputy Chief Counsel for Litigation, who said that the FDA will increase misdemeanor criminal prosecutions for pharmaceutical executives whose companies are […]
FDA Message to Pharma: Misdemeanor Criminal Charges can Result from Promoting Off-Label Drug Uses
The FDA should target for misdemeanor criminal prosecution the executives of pharmaceutical companies which promote unauthorized uses of their medicines. This is the latest message from Eric Blumberg, Deputy Chief […]