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  • Regulatory NewsRegulatory News

    House E&C Offers Recommendations to Improve 340B Drug Pricing Program

    The House Energy & Commerce (E&C) Committee on Wednesday released an 80-page report outlining issues and recommendations to improve the 340B drug pricing program, which helps reduce the prices of certain drugs for participating hospitals, health centers and other entities that provide care for vulnerable patients. The 80-page report follows an October House E&C hearing in which hospital executives pushed back on the idea that the 340B program should be narrowed o...
  • HRSA Closes Loophole for Quadrivalent Vaccines

    Regulators at the Health Resources and Services Administration (HRSA) have finally closed a loophole in the National Vaccine Injury Compensation Program that had left legislators scrambling to pass a fix over the summer. Background To incentivize research and development in vaccine products, the US government has set up a special fund, known as the National Vaccine Injury Compensation Program (NVICP), as well as a specific vaccine claims court system. The two are intend...
  • US HRSA Proposes Regulating Face, Hand Transplants

    The US Health Resources Services Administration (HRSA) wants to regulate face, hand, and other body part transplants much like it does for other organ transplants, according to the Washington Post . HRSA's proposal would also institute: waiting lists run by the United Network for Organ Sharing (UNOS); donor matching systems; organ distribution systems; and systems to test for diseases and infections. HRSA officials noted that they were seeking to issue the...