The FDA is now accepting requests to take part in a pilot program that the company hopes will carry again pharmaceutical manufacturing to the US.
The US FDA is accepting requests to take part within the FDA PreCheck pilot program. FDA PreCheck is designed to strengthen the home pharmaceutical provide chain by rising regulatory predictability, facilitating the development of producing websites within the US, and streamlining facets of pharmaceutical manufacturing facility assessments upfront of a selected product software.
FDA introduced the initiative in August 2025 and commenced accepting functions on February 1, 2026.
“After 35 years of globalists taking pharmaceutical manufacturing abroad, the FDA is taking daring steps to carry it again,” stated FDA Commissioner Marty Makary, MD, MPH. “The PreCheck program is one in all a number of highly effective incentives we’re offering to make the US pharmaceutical manufacturing sector extra resilient and aggressive.”
The company will choose an preliminary cohort of latest pharmaceutical manufacturing services and start conducting PreCheck actions in 2026. Services shall be chosen primarily based on total alignment with nationwide priorities throughout a number of choice standards, akin to merchandise to be manufactured, section of facility growth, timeline to producing pharmaceutical merchandise for the U.S. market, and innovation in facility growth. Extra precedence consideration shall be given to services producing essential drugs for the U.S. market.
The FDA integrated intensive business suggestions into this system design primarily based on feedback made through the “Onshoring Manufacturing of Medicine and Organic Merchandise” public assembly held on Sept. 30, 2025, and public feedback obtained by Federal Register publication. Trade strongly supported early engagement throughout facility growth and streamlined documentation processes.
FDA PreCheck consists of two phases. In Section 1, the Facility Readiness Section, chosen producers will interact with FDA for early technical recommendation earlier than a facility is operational by pre-operational opinions and utilization of a facility-specific Drug Grasp File to facilitate environment friendly analysis of facility-specific parts previous to, and in assist of, the submission of a drug software. In Section 2, the Software Submission Section, FDA and candidates construct upon Section 1 and interact by pre-submission conferences and inspections to resolve points and expedite assessments of producing info in a drug software.
Extra info, together with eligibility and choice standards, is offered on the FDA PreCheck internet web page.
