The pharmaceutical industry won’t let FDA force it to report quality metrics without a fight.
After two years of collaborating on a set of industrywide pharmaceutical quality metrics, FDA and industry are clashing over enforceability.
A rift between the agency and industry groups that surfaced at a public meeting in August has since widened, judging...
Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.
One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.
A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.
George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.
