(Reuters) -The U.S. Food and Drug Administration on Thursday announced a new program to strengthen the domestic pharmaceutical supply chain by facilitating construction of manufacturing sites.
The program, called FDA PreCheck, aims to streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements, the FDA said.
The program also 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 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 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 and Maju Samuel)
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