CDER’s “Concept of Operations:” Managing a New Regulatory Model

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CDER’s “Concept of Operations”
Managing a New Regulatory Model

YOU will need to understand the FDA’s new vertically integrated, programmatically aligned environment: How it may affect the new roles and responsibilities of CDER and ORA … who to talk to and how to talk to them … timeframes to expect … best ways to encourage FDA to meet its commitments.

Under its “One Quality Voice” initiative — OPQ will create teams of experts that integrate application review, facility inspection, data management and surveillance, for individual drug products. So, your next NDA or ANDA will be assigned to a single group of reviewers, investigators and other regulatory decision-makers who work together during each phase of your product’s development, manufacture and marketing.

That means you’ll work with the same people year after year, getting to know them, collaborate with them and shape the future of your products and your company. No more searching through the FDA telephone tree to find the right contact to answer your questions; no more random, unfamiliar investigators showing up for inspections; no more misunderstandings, delays or lost opportunities because the  offices you are dealing with aren’t communicating with each other.

CDER’s “Concept of Operations” will provide you with a roadmap to working with OPQ, including:

  • New offices within the super office — Office of New Drug Products, Office of Testing and Research, Office of Surveillance, Office of Biotech Products, and more
  • What types of experts will be on an integrated quality assessment team
  • How you will meet and communicate with them
  • How the integrated quality assessment approach will affect the way your facility inspections are conducted, including objectives and criteria investigators will use
  • How OPQ will evaluate critical quality attributes of your product to determine its risks.

You’ll also get OPQ organizational charts, responsibility matrices, process flowcharts and more to help you navigate this new world of collaboration.

Order your copy of CDER’s “Concept of Operations:” Managing a New Regulatory Model for a clear picture of CDER’s “Concept of Operations” and understand how to work with their new agency-assigned team of experts.

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PDF Edition


Available Format

PDF Edition — $397

Note: This publication will be available in PDF format by Aug. 15, 2018.

Who Will Benefit

  • Drug application developers
  • QA/QC staff
  • Regulatory affairs/compliance staff
  • Senior executives
  • Consultants

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