On June 22, 2012, the United States Court of Appeals for the District of Columbia Circuit affirmed that a partnership which utilized a Son of Boss tax shelter 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_fidj2012-08-01 12:32:512025-12-10 10:30:50U.S. Court of Appeals for the D.C. Circuit Affirms Son of Boss Accuracy-Related Penalty
In late 2011, the U.S. Food and Drug Administration (“FDA“) launched an initiative targeting marketers of gastric band surgery following the death of five patients. The FDA is concerned that […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2012-07-26 07:36:572025-12-16 10:12:30FDA Targets Gastric Band Surgery Advertisements
On July 11, 2012, the Atlanta based Eleventh Circuit Court of Appeals issued its opinion in Shockley v. IRS, __ F.3d ____, (11th Cir.) available here, and overruled the U.S. […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2012-07-23 14:45:232025-12-10 10:27:04Eleventh Circuit Rules that Tax Court Petition by Former owners Suspended the Statute of Limitations
On July 13, 2012, the U.S. Food and Drug Administration (“FDA“) issued a Draft Guidance document entitled “Medical Devices: The Pre-Submission Program and Meetings with FDA Staff” (“the Guidance”). The […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2012-07-20 08:26:492025-12-10 10:22:08FDA Issues Draft Guidance for Medical Device Pre-Submission Program
As we previously reported, in September 27, 2010, the Federal Trade Commission (“FTC“) filed a complaint against POM Wonderful LLC (“POM“) for allegedly making unsubstantiated claims, which were also false […]
On July 16, 2012, the =Senate Permanent Subcommittee on Investigations released a 335 page report detailing numerous and sustained AML regulatory compliance deficiencies over the past decade at London headquartered […]
On July 5, 2012, K-V Pharmaceutical Company (“KV“) filed a complaint against the U.S. Food and Drug Administration (“FDA“) in the U.S. District Court for the District of Columbia regarding […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2012-07-18 14:15:292026-01-07 15:56:35Drugmaker Sues FDA over Orphan Drug Exclusivity
On July 5, 2012, the U.S. Food and Drug Administration (FDA) announced its intent to take enforcement action against companies that manufacture and distribute certain unapproved drugs that contain oxycodone. […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2012-07-17 14:56:382025-12-10 10:20:15FDA to Take Enforcement Action against Companies Marketing Unapproved Oxycodone Drugs
As required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), the U.S. Food and Drug Administration (FDA) issued a proposed rule on July 3, 2012 to establish […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2012-07-12 09:07:262025-12-16 08:52:11FDA Proposes Unique Device Identification System for Medical Devices
According to recent reports presented by BioFlorida, biotechnology funding in Florida tripled in 2011 and the growth of new biotech and medical device companies in Florida outpaced the national average. […]
U.S. Court of Appeals for the D.C. Circuit Affirms Son of Boss Accuracy-Related Penalty
On June 22, 2012, the United States Court of Appeals for the District of Columbia Circuit affirmed that a partnership which utilized a Son of Boss tax shelter to […]
FDA Targets Gastric Band Surgery Advertisements
In late 2011, the U.S. Food and Drug Administration (“FDA“) launched an initiative targeting marketers of gastric band surgery following the death of five patients. The FDA is concerned that […]
Eleventh Circuit Rules that Tax Court Petition by Former owners Suspended the Statute of Limitations
On July 11, 2012, the Atlanta based Eleventh Circuit Court of Appeals issued its opinion in Shockley v. IRS, __ F.3d ____, (11th Cir.) available here, and overruled the U.S. […]
FDA Issues Draft Guidance for Medical Device Pre-Submission Program
On July 13, 2012, the U.S. Food and Drug Administration (“FDA“) issued a Draft Guidance document entitled “Medical Devices: The Pre-Submission Program and Meetings with FDA Staff” (“the Guidance”). The […]
POM Wonderful and FTC Appeal Initial Decision
As we previously reported, in September 27, 2010, the Federal Trade Commission (“FTC“) filed a complaint against POM Wonderful LLC (“POM“) for allegedly making unsubstantiated claims, which were also false […]
Senate Report Reveals Numerous Sustained AML Deficiencies at HSBC
On July 16, 2012, the =Senate Permanent Subcommittee on Investigations released a 335 page report detailing numerous and sustained AML regulatory compliance deficiencies over the past decade at London headquartered […]
Drugmaker Sues FDA over Orphan Drug Exclusivity
On July 5, 2012, K-V Pharmaceutical Company (“KV“) filed a complaint against the U.S. Food and Drug Administration (“FDA“) in the U.S. District Court for the District of Columbia regarding […]
FDA to Take Enforcement Action against Companies Marketing Unapproved Oxycodone Drugs
On July 5, 2012, the U.S. Food and Drug Administration (FDA) announced its intent to take enforcement action against companies that manufacture and distribute certain unapproved drugs that contain oxycodone. […]
FDA Proposes Unique Device Identification System for Medical Devices
As required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), the U.S. Food and Drug Administration (FDA) issued a proposed rule on July 3, 2012 to establish […]
Florida Biotech Funding Tripled in 2011
According to recent reports presented by BioFlorida, biotechnology funding in Florida tripled in 2011 and the growth of new biotech and medical device companies in Florida outpaced the national average. […]