Susan Haigney

The FDA selected seven companies, including two CGT manufacturers, for its PreCheck Pilot to accelerate domestic manufacturing approvals and bolster supply chain resilience.

USP's Annual Drug Shortages Report reveals a sharp rise in product discontinuations, driven by unsustainable generic pricing, upstream geographic concentration, and manufacturing complexity.

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.