Agency IQ

NOVEMBER 10, 2023

However, FDA’s vision for OPQ to serve as a “single, agency-wide quality oversight program that applies a uniform set of standards to all regulated products, and which integrates quality review, evaluation, and inspection activities under one authority” was first publicized more than a decade earlier.

Pharmaceuticals 40

Pharmaceuticals Small Molecule Science FDA 40

Codon

APRIL 30, 2023

If approved, these wouldn’t be the first gene therapies on the market, but they would be the first gene therapies for a disease that affects something like 100,000 Americans. Read This paper explains how synthetic biology is regulated in Europe. Note: I’m employed by the company and a co-author on the paper.)

Vaccine 52

Vaccine Engineering DNA RNA 52

Codon

APRIL 30, 2023

If approved, these wouldn’t be the first gene therapies on the market, but they would be the first gene therapies for a disease that affects something like 100,000 Americans. Read This paper explains how synthetic biology is regulated in Europe. Note: I’m employed by the company and a co-author on the paper.)

Vaccine 52

Vaccine Engineering DNA RNA 52