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US FDA moves to boost domestic drug manufacturing after Trump push
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US FDA moves to boost domestic drug manufacturing after Trump push
Aug 7, 2025 9:10 AM

Aug 7 (Reuters) - The U.S. Food and Drug Administration

on Thursday announced a new program to speed up construction and

review of drug manufacturing plants in the country to boost

domestic drug supply.

The program, called FDA PreCheck, aims to streamline review

of domestic pharmaceutical plants and eliminate unnecessary

regulatory requirements, in line with President Donald Trump's

executive order in May to shift manufacturing of drugs to the

United States.

"The FDA PreCheck initiative is one of many steps FDA is

taking that can help reverse America's reliance on foreign drug

manufacturing and ensure that Americans have a resilient,

strong, and domestic drug supply," FDA Commissioner Marty Makary

said in a statement.

The regulator in June launched a program to incentivize

drug developers that align with national priorities, including

increased domestic manufacturing, with considerably shorter

review times for their marketing applications.

Several major drugmakers, including AstraZeneca ( AZN ),

Eli Lilly ( LLY ) and Johnson & Johnson ( JNJ ), have pledged

billions of dollars to scale up their U.S. footprint.

The Trump administration has threatened to impose

tariffs on pharmaceutical imports, starting "small" and

eventually hiking it as much as 250% in an effort to boost

domestic production.

The FDA PreCheck program introduces a two-phase approach to

facilitate new U.S. drug manufacturing facilities.

The initial phase would provide for more frequent

communication with the FDA, including for facility design,

construction and pre-production.

The second phase would facilitate pre-application meetings

and early feedback to help streamline the development of

manufacturing and quality control processes, the agency said.

The FDA plans to hold a public meeting on September 30 to

discuss the new program.

(Reporting by Mariam Sunny in Bengaluru; Editing by Shinjini

Ganguli, Maju Samuel and Devika Syamnath)

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