On September 27, 2011, Del Monte Fresh Produce N.A., Inc. (Del Monte) voluntarily dismissed its suit against the U.S. Food and Drug Administration (FDA) which alleged that the Agency had no basis to suggest its cantaloupes were the source of a salmonella panama contamination. Found here, the Notice of Dismissal cites the lifting of the import alert that formed the basis of the suit as its reason for seeking dismissal. The Import Alert, which prevented cantaloupes from Guatemala from being imported into the United States, was lifted the same day.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-10-06 13:19:522026-01-07 15:31:37Del Monte Drops Suit Against FDA After FDA Lifts Import Alert
On September 30, 2011, the U.S. Food and Drug Administration (FDA) announced the release of its draft guidance, entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The Guidance comes as a part of the FDA’s overhaul of its medical device review scheme, as the FDA intends to implement to streamline the way medical devices are reviewed and cleared. As previously reported, the FDA announced its plans to overhaul its entire system for reviewing and clearing medical devices earlier in 2011 and highlighted its intentions to target the “de novo” review process as a means to lessen the burden for manufacturers, while continuing its mission of public safety.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-10-06 13:17:482025-12-09 15:32:27FDA Moves to Streamline De Novo Process
On September 19, 2011, two scientists who have been challenging government funding of human embryonic stem cell (hESC) research filed their Notice of Appeal in the U.S. Court of Appeals […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-10-04 12:08:192025-12-09 15:30:55Scientists Appeal Ruling Allowing Federal Funding for Embryonic Stem Cell Research
Although criminal sanctions against corporate officers for violations for the Food, Drug & Cosmetic Act (FDCA) have been on the books since 1938, federal prosecutors have taken aim at corporate […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-09-22 08:27:362025-12-09 15:32:05Federal Prosecutors Take Aim At Corporate Officers For FDCA Violations With Revived Use Of The Park Doctrine
On September 6, 2011, the U.S. Food and Drug Administration (FDA) issued a Letter to Industry focused on the import entry review process. Importers of medical devices are encouraged 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_fidj2011-09-20 14:29:112025-12-09 15:30:32FDA Issues Letter to Industry Regarding Imports of Medical Devices
On September 13, 2011, the United States District Court for the Middle District of Pennsylvania issued its decision finding that the individual mandate provision of the Patient Protection and Affordable […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-09-20 09:02:592014-11-10 18:16:31Patient Protection and Affordable Care Act Challenges Often Turn On Interpretation of the Court’s Commerce Clause Jurisprudence
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-09-16 10:12:142025-12-09 15:29:52IRS and DOL Release Final Regulatory Review Plans to Help Distressed Sponsors and Retirement Plans
On August 19, 2011, Google entered into a non-prosecution agreement with the United States Department of Justice to settle allegations that the search engine knowingly and improperly assisted Canadian online […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-09-14 13:47:542025-12-09 15:28:30Google Agrees to Forfeit $500 Million As Part of Non-Prosecution Agreement
On September 7, 2011, the U.S. Food and Drug Administration (FDA) announced two new pilot projects to aid tracking of food products, in an effort to prevent the spread of foodborne illness outbreaks.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-09-13 14:16:072025-12-09 15:25:28FDA Announces Implementation of Traceability Projects under FSMA
On September 7, 2011, the Florida Fourth District Court of Appeal upheld a lower court ruling that law enforcement did not violate the Fourth Amendment by using “real time” cell […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-09-13 07:58:512026-01-05 15:17:464th DCA Rules: Real Time Cell Phone Location Tracking Does Not Violate 4th Amendment
Del Monte Drops Suit Against FDA After FDA Lifts Import Alert
On September 27, 2011, Del Monte Fresh Produce N.A., Inc. (Del Monte) voluntarily dismissed its suit against the U.S. Food and Drug Administration (FDA) which alleged that the Agency had no basis to suggest its cantaloupes were the source of a salmonella panama contamination. Found here, the Notice of Dismissal cites the lifting of the import alert that formed the basis of the suit as its reason for seeking dismissal. The Import Alert, which prevented cantaloupes from Guatemala from being imported into the United States, was lifted the same day.
FDA Moves to Streamline De Novo Process
On September 30, 2011, the U.S. Food and Drug Administration (FDA) announced the release of its draft guidance, entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The Guidance comes as a part of the FDA’s overhaul of its medical device review scheme, as the FDA intends to implement to streamline the way medical devices are reviewed and cleared. As previously reported, the FDA announced its plans to overhaul its entire system for reviewing and clearing medical devices earlier in 2011 and highlighted its intentions to target the “de novo” review process as a means to lessen the burden for manufacturers, while continuing its mission of public safety.
Scientists Appeal Ruling Allowing Federal Funding for Embryonic Stem Cell Research
On September 19, 2011, two scientists who have been challenging government funding of human embryonic stem cell (hESC) research filed their Notice of Appeal in the U.S. Court of Appeals […]
Federal Prosecutors Take Aim At Corporate Officers For FDCA Violations With Revived Use Of The Park Doctrine
Although criminal sanctions against corporate officers for violations for the Food, Drug & Cosmetic Act (FDCA) have been on the books since 1938, federal prosecutors have taken aim at corporate […]
FDA Issues Letter to Industry Regarding Imports of Medical Devices
On September 6, 2011, the U.S. Food and Drug Administration (FDA) issued a Letter to Industry focused on the import entry review process. Importers of medical devices are encouraged to […]
Patient Protection and Affordable Care Act Challenges Often Turn On Interpretation of the Court’s Commerce Clause Jurisprudence
On September 13, 2011, the United States District Court for the Middle District of Pennsylvania issued its decision finding that the individual mandate provision of the Patient Protection and Affordable […]
IRS and DOL Release Final Regulatory Review Plans to Help Distressed Sponsors and Retirement Plans
In January 2011, President Obama issued Executive Order 13563, Improving Regulation and Regulatory Review, requiring agencies to review current regulations and determine if they are necessary and effective.
Google Agrees to Forfeit $500 Million As Part of Non-Prosecution Agreement
On August 19, 2011, Google entered into a non-prosecution agreement with the United States Department of Justice to settle allegations that the search engine knowingly and improperly assisted Canadian online […]
FDA Announces Implementation of Traceability Projects under FSMA
On September 7, 2011, the U.S. Food and Drug Administration (FDA) announced two new pilot projects to aid tracking of food products, in an effort to prevent the spread of foodborne illness outbreaks.
4th DCA Rules: Real Time Cell Phone Location Tracking Does Not Violate 4th Amendment
On September 7, 2011, the Florida Fourth District Court of Appeal upheld a lower court ruling that law enforcement did not violate the Fourth Amendment by using “real time” cell […]