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…civil forfeiture complaint pursuant to 21 U.S.C. § 334 in the U.S. District Court for the District of South Carolina to seize a large quantity of kratom products, including finished…
…in Western Europe, Central and South America accounted for the highest average number of subjects per site. Usually, only one clinical investigator oversees a clinical trial site. OIG also determined…
The Consumer Products Safety Commission (“CPSC”) yesterday announced that former South Carolina State Superintendent of Education Inez Moore Tenenbaum has been sworn in as the ninth CPSC Chairman. We previously…
…Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Carolina, Oklahoma, Ohio, Oregon, South Carolina, Tennessee, Texas, Utah, Vermont, Washington, West Virginia, and Wyoming. UPDATE: A…
…a representational standing argument in their court papers based on several alleged injuries flowing from FDA’s August 24, 2006 PLAN B approval. The court did not buy the argument and…
…lawsuit. The District Court did not buy Genentech’s distinction and dismissed Genentech’s action without prejudice after an oral hearing. The Court’s decision implies that the only recourse Genentech has is…
…deposits and withdrawals between different accounts. The opinion explains that Banks used bogus information to open accounts at the FOREX.com international exchange system, ostensibly to buy and sell foreign currencies….
…to allow Americans to buy safe and effective drugs from other countries . . . .” This cryptic statement appears to refer to the importation of finished pharmaceuticals, though the…
…as part of spon-con on local news stations, and demonstrates how his team was able to buy local news time to promote “the world’s first sexual health blanket.”) With regard…
…original Opana ER not substitutable, but Endo needed some time to shift the market to its crush-resistant product. To buy some time, Endo sued Impax for patent infringement and triggered…
…allege economic injuries, like buying antibiotic-free meat to mitigate the risk of exposure to antibiotic-resistant bacteria or buying separate work clothes so that their care for infected patients does not…
…we’re protecting people’s sensitive information via geolocation data that people can buy to track with great precision” said Khan, “whether people are going to addiction facilities or places of worship…
…laboratory). There were some limitations to the umbrella EUA; for example, it only allowed for authorization for use in moderate- or high-complexity CLIA laboratories. If companies wanted to pursue a…
…government agencies, including FDA, it does not speak for all federal agencies (e.g., SEC). Foreign regulators and state and local enforcement agencies must buy into DOJ policy for true effectiveness….
…in compliance with the REMS provisions for these drugs. We note that FDA’s website includes numerous warnings that patients should not buy Mifeprex or mifepristone over the internet because doing…