…the time to pursue civil cases against every individual employee who may be liable for misconduct, and we cannot afford to delay corporate resolutions because a bureaucratic rule suggests that…

…and its pharmacist-owner. Federal Court Orders San Antonio-Area Pharmacy and Pharmacist to Pay $275,000 Civil Penalty in Case Alleging Unlawful Opioid Distribution, Oct. 11, 2023 (DOJ Press Release). Several weeks…

…processes for submission of electronic MDRs (eMDRs) to FDA, in accordance with the Medical Device Reporting: Electronic Submissions Requirements Final Rule (eMDR Final Rule) published in the Federal Register of…

…Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; ADB-FUBINACA; ADB-CHMINACA; Cyclopropyl Fentanyl; Methoxyacetyl Fentanyl; para-Fluoro Butyrfentanyl; Tramadol; Pregabalin; Cannabis Plants and Resin; and Eight Additional Substances; Request for…

…you have a good relationship with the review team, Dr. Maisel encourages a brief phone call or quick email to obtain informal feedback. Dr. Maisel also discussed disposition of already…

On January 12, 2021, FDA issued an Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (“AI/ML Action Plan”) and a discussion paper on their Proposed Regulatory…

…to manufacturer rebates to Medicare Part D plans, Medicaid Managed Care Organizations (MCOs) and their pharmacy benefits managers (PBMs). The Final Rule was published in the Federal Register on November…

…request for review. In our view, these additional details are essential to a well-established process. We hope that FDA will provide additional clarity in its final draft so that the…

…liability can be imposed on a responsible corporate officer regardless of whether that individual knew of the violation.  In contrast, the CMPs in the TMJI case were imposed for “knowing”…

…thus causing clinical laboratories that purchased and used those tests to submit false claims for reimbursement to federal health care programs.  Interestingly, the government also alleged a second “tier” of…

…Northern District of Illinois (Eastern Division) the imposition of the maximum allowable monetary penalties under the Controlled Substances Act (“CSA”).  In this case, the federal government brought a civil action…

…gained in popularity. TINA.org alleges that many products marketed with unqualified Made in the USA claims violate the standard set by FTC, i.e., all or virtually all components must be…

…2013 decision from the U.S. District Court for the Northern District of California finding that a first-in-the-nation Safe Drug Disposal Ordinance passed by the Alameda County, California Board of Supervisors…

…through 2013 in response to concerns about the growth of the medical marijuana industry. Officials in California, Oregon and Washington also reported conducting criminal investigations and prosecutions or civil suits…

…Manufacturers of America (PhRMA) sued the agency on various statutory and procedural grounds. See, e.g., AstraZeneca Pharmaceuticals v. Becerra, No. 1:21-cv-00027-LPS, 2021 WL 2458063 (D. Del. Jan. 12, 2021). Despite…