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Fujifilm to Invest Over 200 Billion yen (2 Billion USD) to Establish New Large-Scale Cell Culture Manufacturing Site for Biopharmaceuticals in the U.S.A.

The Pharma Data

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. This new facility will offer large-scale cell culture manufacturing of bulk drug substance with 8 x 20,000L bioreactors (physical volume), with the potential to expand and add a further 24 x 20,000L bioreactors based on market demand.

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Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Agency IQ

In 2012, the passage of the FDA Safety and Innovation Act (FDASIA) created a new requirement for sponsors to submit all drug submissions, including clinical trial applications, in an electronic format as specified by FDA guidance. Investigational New Drug, or IND, safety reports) to the FDA in E2B(R3) format.

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