- 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.