…(see our post here). The rule also establishes two new safe harbors: one for rebates paid to Medicare Part D plans and Medicaid Managed Care plans, or their PBMs, if…

…public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context…

…difficult it will be to pass the statutory hurdle and obtain FDA approval to import drugs from Canada, and also pointed out that Canada’s Minister of Health has issued an…

…bill largely deals with the nation’s transportation infrastructure, Section 90006 delays the so-called “rebate rule,” a Trump-era rule finalized by the Office of the Inspector General (OIG) of the U.S….

…by FSIS so the Agency can prevent false or misleading labeling. Although this will help industry avoid delays associated with rulemaking, labels approved during the interim (pre-final rule) period may…

…OIG final rule, published on November 30, 2020, which amends the Federal health care program antikickback statute safe harbors as they apply to drug rebates paid to Medicare Part D…

…Sponsor can demonstrate that it has consistently imported eligible prescription drugs in accordance with Section 804 and the Final Rule, the SIP Sponsor may submit a supplemental proposal to FDA…

…QMSR retains definitions of some terms that do not appear in ISO 13485 but are necessary to ensure alignment with the Federal Food, Drug, and Cosmetic Act (FDCA), such as…

…informed, person-centered decisions related to pain care together.” Id. It is intended for clinicians (primary care, physicians, nurse practitioners, physician assistants, and oral health practitioners) who provide pain care to…

…These agreements are voluntary, and in exchange for signing them a manufacturer obtains the benefit of coverage or procurement under federal health care programs. The Congressional sponsors of these programs…

…in a clinical trial intended to evaluate another drug when the concomitant therapy is not part of the clinical trial evaluation, as this is not an investigational use of the…

…Act (ACA) and the agencies’ existing regulations, and is arbitrary and capricious. Among other arguments, the complaint asserts that the NBPP rule violates the ACA’s cost-sharing cap, which mandates that…

…release testing alone is not sufficient to assess comparability and that additional characterization testing or in process testing be conducted based on risk assessment and developmental studies. In some cases,…

…to pain management related to sickle cell disease or cancer-related pain treatment, palliative care and end-of-life care. Id. at 1. Recommendations The 2022 guideline recommendations address four general areas: (1)…

…initial critical quality attributes, potency assay development plans during clinical development, and a quality target profile. As the product advances in clinical development, expectations are that the potency test be…