FDA Launches ‘PreCheck’ Program; AstraZeneca, Acadia Drugs Set Back

FDA launches ‘PreCheck’ program; AstraZeneca, Acadia drugs set back

The agency’s program will be open to pharmaceutical facilities that align with “national priorities.” Elsewhere, a self-administered lupus drug was turned back and MeiraGTx picked up another gene therapy.

FDA Launches PreCheck Pilot to Onshore Pharmaceutical Manufacturing

The FDA has officially launched the FDA PreCheck pilot program, a strategic initiative designed to strengthen the domestic pharmaceutical supply chain and incentivize “onshoring” of drug production. By offering increased regulatory predictability and streamlining the assessment of new manufacturing facilities, the agency aims to reduce the hurdles associated with building and operating sites within the U.S. This program follows extensive industr…

Pharma Pulse: Onshoring the Supply Chain

In today’s Pharma Pulse, the FDA launches its "PreCheck" pilot to speed up domestic factory approvals, while new SELECT trial data shows that semaglutide significantly slashes hospital admission rates.