Drugs - December 2017

  • US: Mepergan Fortis Capsules; Final Decision on Proposal to Refuse Approval of Supplemental New Drug Application; Availability of Final Decision

  • US: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products

  • US: Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year

  • US: Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program for CY 2018

  • US: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule

  • US: Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical

Center Payment Systems and Quality Reporting Programs

  • US: Unique Device Identification; Direct Marking of Devices

  • US: Final Adjusted Aggregate Production Quotas for Schedule I and II Controlled

Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine and Phenylpropanolamine for 2017

  • US: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment

Parameters for 2019

  • US: Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for

Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal

Disease Quality Incentive Program

  • EU: UPDATE - Guidance published by Member States on the implementation of the Falsified Medicines Directive

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