Day: July 7, 2022

When the Regenerative Medicine Advance Therapy (RMAT) designation was proposed in 2016, it was assumed to be an easier expedited approval pathway specific for stem cells and other regenerative therapies, compared to the Breakthrough Therapy (BTD) designation. But it with about 40% approval rates and only 3 approvals, it may be turning out to be … Read more

Manufacture and distribution of drugs and biologics involve various parties with diverse responsibilities, and it was always confusing as to what regulatory requirements apply to them, till now. Who needs to register with FDA, who needs to pay fees, who needs to be licensed by other authorities, etc.? This week, FDA’s newest Guidance Document list … Read more