• Industry Wants FDA to Hit the Brakes on Quality Metrics Program

The US Food and Drug Administration’s (FDA) proposed quality metrics program is proving to be a bitter pill for the pharmaceutical industry to swallow.

  • FDA Unveils Regulatory Science Progress Report

The report, covering fiscal years 2015 and 2016, notes significant US Food and Drug Administration (FDA) progress in refining non-clinical and clinical tools to better evaluate medical products, advancing manufacturing and quality, and enhancing internal IT tools to support the scientific review of regulatory applications.

  • European Regulatory Roundup: EMA to Revise Guideline on Quality of Inhaled Medical Products (30 March 2017)
  • Regulatory Recon: Novartis Eyes First FDA CAR-T Approval; FDA Rejects Mylan’s Generic of GSK’s Advair (30 March 2017)
  • Democrats Propose Wide-Ranging Bill to Lower Drug Costs

House and Senate Democrats late Wednesday offered up a host of new provisions to bring down the rising cost of pharmaceuticals, many of which have been publicly opposed by the pharmaceutical industry.

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