The U.S. Securities and Exchange Commission said a district court judge affirmed the agency’s settlement of insider trading charges leveled at David Parker, bringing to a close a complaint filed eight years ago. The 2012 complaint alleged that Parker had benefitted from insider information regarding the acquisition of Advanced Medical Optics Inc. (AMO), by Abbott Laboratories of Abbott Park, Ill. That insider information was alleged to have been provided by then-AMO CEO James Mazzo, whose disclosure was purported to have been to former major league baseball player Doug DeCinces. DeCinces was alleged to have disclosed the information to four others, including Parker. Parker admitted to no wrongdoing but will have to pay nearly $400,000 in disgorgement and penalties.
The U.S. FDA is looking to expand its weekly entry filing program for U.S. imports coming from foreign trade zones (FTZ). Under the program, which currently is available only for some FDA-regulated products, filers could submit a single entry estimating the amount of merchandise they anticipate moving from an FTZ for U.S. consumption during a seven-day period. The weekly filing is expected to contain information for multiple products, which should be “significantly less burdensome on a per-product basis,” the FDA said in a notice scheduled for publication in Friday’s Federal Register. The agency is recommending that importers wanting to file a weekly entry of FDA-regulated products with U.S. Customs and Border Protection should first request a preliminary assessment from the FDA. Comments on the FDA’s proposed revision should be submitted by March 3.
The U.K. National Institute for Health and Care Excellence said balloon dilation for blocked eustachian tubes is supported by the evidence for both safety and efficacy. The procedure ordinarily commences with transnasal device insertion, with device inflation with saline solution typically limited to 10-12 bar for 120 seconds. The procedure can be done in lieu of tympanostomy but is typically undertaken only in patients refractory to medical management.