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On Wednesday, the Food and Drug Administration announced that, in Fiscal Year 2019, the agency approved a total of 1,171 generic drugs, an all-time record, following a record 971 approvals in Fiscal Year 2018 and a record 937 approvals in Fiscal Year 2017.
Today, the U.S. Department of Health and Human Services published a new Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics. Individual patients, as well as the health of the public, benefit when opioids are prescribed only when the benefit of using opioids outweighs the risks. But once a patient is on opioids for a prolonged duration, any abrupt change in the patient’s regimen may put the patient at risk of harm, and should include a thorough, deliberative case review and discussion with the patient. The HHS Guide provides advice to clinicians who are contemplating or initiating a change in opioid dosage.
The Department of Health and Human Services (HHS) announced proposed changes to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) and the Federal Anti-Kickback Statute.
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