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IPQ Monthly Update – December 2018 in Review

IPQ Monthly Update – November 2018 in Review

IPQ Monthly Update – September/October 2018 in Review

IPQ Monthly Update – July/August 2018 in Review

IPQ Monthly Update – May/June 2018 in Review

IPQ Monthly Update – March/April 2018 in Review

IPQ Monthly Update – January/February 2018 in Review

During January and February, IPQ was focused heavily on the emerging challenges faced by regulators due to the rapidly increasing number of applications encompassing new products and therapies, technologies and processes. The three stories in this issue explore: ● how FDA’s generic drug review process is evolving with user fee support to address the increasing number and complexity of products emerging through it ● how CBER is responding to the wave of advanced therapies it is now facing, and ● a CDER/CBER view of the current biologic product CMC review landscape and the BLA challenges, accomplishments, and learnings.

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CLICK HERE for the IPQ Monthly Update – December 2018 in Review

IPQ takes its readers from:

● the headlines to the forces driving them

● regulations and policies to their underlying intent

● the pieces of the puzzle to their interconnection

● requirements to implementation pathways

● random data to critical trends

● the sidelines to helping shape the outcome

● compliance problems to proactive quality tools

● information to intelligence


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