FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections

Read the full press release:  Press Announcements > FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections - FDA.gov:

"The U.S. Food and Drug Administration has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom."

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FDA Finalizes Guidance on Emerging Manufacturing Tech Program | RAPS

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Read the full article: FDA Finalizes Guidance on Emerging Manufacturing Tech Program | RAPS:

"The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing how drugmakers can participate in the agency's program to advance the use of emerging manufacturing technologies, such as continuous manufacturing or 3D printing."

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Read the FDA guidance:
Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization - FDA (pdf)


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