On June 28 – 29, 2011, Genentech appeared before the U.S. Food and Drug Administration (FDA) asking the Agency to reconsider its proposal to revoke Avastin’s approval for use in the treatment of breast cancer patients. The FDA approved Avastin three years ago through an accelerated approval process because Avastin is used to treat serious diseases and fills an unmet medical need. This accelerated approval process provides patients access to promising new drugs for treatment of serious or life-threatening conditions while awaiting the results of phase IV confirmatory clinical trials. If subsequent clinical trials fail to confirm the drug’s clinical benefit, the FDA may take action to remove the drug from the market, see 21 C.F.R. § 314, subpart H. This marked the first time the FDA has held a hearing to consider a company’s appeal of such a decision.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-07-11 10:00:492025-12-09 14:37:27FDA to Hear Avistan’s Appeal Regarding Proposed Revocation of Drug Approval
As the deadline nears for reporting Uncertain Tax Positions (“UTPs”) to the IRS, practitioners and organizations continue to protest the lack of guidance on various disclosures. Speaking in a webcast on June 28, a PricewaterhouseCoopers representative relayed that the firm is specifically concerned with what it means to record a reserve and how to treat non-GAAP taxpayers. Similarly, the Tax Executives Institute recently called on the IRS to address issues like filing requirements and transfer pricing. Amid all of this uncertainty, we present pre-filing strategiesâ€â€as suggested by BNAâ€â€for resolving future uncertain tax positions.
On June 30, 2011, Fuerst Ittleman lawyer Robert Becerra gave a presentation on “Criminal Prosecution in the International Trade Arena: Conducting Business While Staying Out of Jail” to the National […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-07-01 15:00:592025-12-09 14:36:52Robert Becerra Presentation to National Assocation of Purchasing Management
Taxpayers who are unfairly pinned with spousal tax liabilities may soon be met with relaxed filing restrictions for “innocent spouse relief,” a recent USA Today article reports.
On June 23, 2011, the Supreme Court ruled in Pliva, Inc. v. Mensing that federal law preempts state tort law suits against generic drug manufacturers for failure to provide adequate warning labels. The decision comes two years after Wyeth v. Levine in which the Court held that federal drug laws did not preempt such suits against brand-name manufacturers.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-06-30 15:21:012026-02-10 09:27:11Supreme Court Holds Failure to Warn Suits Against Generic Drug Manufacturers Are Preempted By Federal Law
On June 14, 2011, the U.S. Government Accountability Office (GAO) released a new report on the U.S. Food and Drug Administration’s (FDA) oversight of medical device recalls. The report determined […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-06-30 15:18:032025-12-09 14:35:37GAO Recommends Increased FDA Oversight of Medical Device Recalls
On March 23, 2011, President Obama signed into law the Patient Protection and Affordable Care Act (PPACA). On March 30, 2011, he signed the Health Care and Education Reconciliation Act of 2010, amending the PPACA (collectively “the 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_fidj2011-06-29 15:07:032014-11-10 18:19:53New Excise Tax for Medical Devices and Prescription Drugs
As we previously reported here, National Taxpayer Advocate Nina Olson reported numerous problems with the Internal Revenue Service’s (IRS) reliance on automated customer service available through Taxpayer Assistance Centers (TACs).
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-06-29 15:03:062025-12-09 14:34:41IRS Struggles to Deal with Increasing Tax Related Identity Theft
Switzerland is seeking to resolve “past fiscal problems” with the US while discussing the implementation of the new U.S. Foreign Account Tax Compliance Act (FATCA).
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-06-29 15:01:142025-12-09 13:48:39Swiss Officials Address Previous Fiscal Issues while Discussing the Implementation of the FATCA
Tax practitioners recently commented on the IRS’s guidance regarding the benefits of its second Offshore Voluntary Disclosure Initiative (OVDI). Several tax practitioners said that the 2011 initiative will likely encourage […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-06-29 14:58:352025-12-09 13:56:47IRS Guidance on the Offshore Voluntary Disclosure Program Likely to Increase Participation
FDA to Hear Avistan’s Appeal Regarding Proposed Revocation of Drug Approval
On June 28 – 29, 2011, Genentech appeared before the U.S. Food and Drug Administration (FDA) asking the Agency to reconsider its proposal to revoke Avastin’s approval for use in the treatment of breast cancer patients. The FDA approved Avastin three years ago through an accelerated approval process because Avastin is used to treat serious diseases and fills an unmet medical need. This accelerated approval process provides patients access to promising new drugs for treatment of serious or life-threatening conditions while awaiting the results of phase IV confirmatory clinical trials. If subsequent clinical trials fail to confirm the drug’s clinical benefit, the FDA may take action to remove the drug from the market, see 21 C.F.R. § 314, subpart H. This marked the first time the FDA has held a hearing to consider a company’s appeal of such a decision.
Strategies for Resolving Uncertain Tax Positions
As the deadline nears for reporting Uncertain Tax Positions (“UTPs”) to the IRS, practitioners and organizations continue to protest the lack of guidance on various disclosures. Speaking in a webcast on June 28, a PricewaterhouseCoopers representative relayed that the firm is specifically concerned with what it means to record a reserve and how to treat non-GAAP taxpayers. Similarly, the Tax Executives Institute recently called on the IRS to address issues like filing requirements and transfer pricing. Amid all of this uncertainty, we present pre-filing strategiesâ€â€as suggested by BNAâ€â€for resolving future uncertain tax positions.
Robert Becerra Presentation to National Assocation of Purchasing Management
On June 30, 2011, Fuerst Ittleman lawyer Robert Becerra gave a presentation on “Criminal Prosecution in the International Trade Arena: Conducting Business While Staying Out of Jail” to the National […]
Relaxed Restrictions for Tough “Innocent Spouse Relief” Rules
Taxpayers who are unfairly pinned with spousal tax liabilities may soon be met with relaxed filing restrictions for “innocent spouse relief,” a recent USA Today article reports.
Supreme Court Holds Failure to Warn Suits Against Generic Drug Manufacturers Are Preempted By Federal Law
On June 23, 2011, the Supreme Court ruled in Pliva, Inc. v. Mensing that federal law preempts state tort law suits against generic drug manufacturers for failure to provide adequate warning labels. The decision comes two years after Wyeth v. Levine in which the Court held that federal drug laws did not preempt such suits against brand-name manufacturers.
GAO Recommends Increased FDA Oversight of Medical Device Recalls
On June 14, 2011, the U.S. Government Accountability Office (GAO) released a new report on the U.S. Food and Drug Administration’s (FDA) oversight of medical device recalls. The report determined […]
New Excise Tax for Medical Devices and Prescription Drugs
On March 23, 2011, President Obama signed into law the Patient Protection and Affordable Care Act (PPACA). On March 30, 2011, he signed the Health Care and Education Reconciliation Act of 2010, amending the PPACA (collectively “the Act”).
IRS Struggles to Deal with Increasing Tax Related Identity Theft
As we previously reported here, National Taxpayer Advocate Nina Olson reported numerous problems with the Internal Revenue Service’s (IRS) reliance on automated customer service available through Taxpayer Assistance Centers (TACs).
Swiss Officials Address Previous Fiscal Issues while Discussing the Implementation of the FATCA
Switzerland is seeking to resolve “past fiscal problems” with the US while discussing the implementation of the new U.S. Foreign Account Tax Compliance Act (FATCA).
IRS Guidance on the Offshore Voluntary Disclosure Program Likely to Increase Participation
Tax practitioners recently commented on the IRS’s guidance regarding the benefits of its second Offshore Voluntary Disclosure Initiative (OVDI). Several tax practitioners said that the 2011 initiative will likely encourage […]