…decision lowers the standard for the government to withhold from disclosure confidential commercial or financial information it receives from regulated industry. In their post, Anne Walsh and Ricardo Carvajal describe…

…FDA would not be ordered to require egg producers to label commercial eggs as being from “free range” or “cage free” hens, or from “caged hens.” Compassion over Killing v….

…false certifications that the products met safety standards. Even though the government touts this case as the “First-Ever Criminal Prosecution for Failure to Report” under the CPSA, the allegations describe…

Earlier this month, the Department of Justice announced another settlement in a Medicaid Rebate False Claims Act (FCA) case. In this case, United States ex rel. Streck v. Bristol-Myers Squibb…

…Investigators may also conduct targeted inspections rather than routine cyclic inspections as part of the local DEA office’s annual workplan if the registrant reported controlled substance thefts/losses or were the…

…DEA may issue a final rule on electronic prescriptions (the agency issued an interim final rule on March 31, 2010) and a proposed rule on transporting controlled substances by ambulance,…

…“Laboratory supply,” as defined by the MCA, is “a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General, which contains chemicals,…

…evaluate ramifications of potential enforcement activities, including administrative, civil and criminal actions against it. Register for this webinar here. Participants will receive a copy of Chapters 11 (Devices: Medical Device…

…force of federal, state, local, and tribal law agencies to identify opioid cases for federal prosecution, facilitate interdiction efforts, and tailor their district’s response to the needs of their communities;…

…practices that cause, or are likely to cause, substantial injury to consumers that they cannot avoid, and that do more harm than good.” Stating that the FTC Act “may apply”…

…under the federal Controlled Substances Act and DEA regulations pose serious health risks to patients for undertreatment and worse, and to employees for overdose and death. Employee diversion can also…

…that had her audience paying attention, even if they weren’t necessarily singing along. Of course, the traditional corporate enforcement chart-toppers were all there for the DAG. Prevent corporate wrongdoing before…

…2024. The memorandum is part of CMS’s efforts to engage with the public on the implementation of the Negotiation Program. These efforts also include national stakeholder calls, quarterly strategic meetings,…

…and civil trial litigation and investigations under the Food, Drug, and Cosmetic Act, Federal Trade Commission Act, Consumer Product Safety Act, and Federal data privacy laws. He also held leading…

…further proceedings in the case. Why this Case Matters This case demonstrates that a court can consider a provider’s actions taken in response to public FDA safety notices when determining…