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 […]
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 […]
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).”
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 […]
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 […]
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 […]
Article 23 of Brazilian Law No. 11.727 became effective on January 1, 2009 defining a “privileged fiscal regime” for transfer pricing purposes. The law defined privileged fiscal regime (“regime fiscal […]
