FDA plans on publishing further GMP and CMC Guidances for Combination Products

FDA`s Office of Combination Products (OCP) will be sharing its growing knowledge base through new guidances and updates to its existing library that will help Combination Product (CP) manufacturers better understand the regulatory expectations and navigate the shoals of marketing clearance.

With eight years of experience in coordinating the flow of applications and addressing the questions and unique challenges presented by the growing array of combination products entering the marketplace, OCP has targeted completing several guidance and regulation initiatives during 2011.
The new CP guidances will cover: 

  • chemical action 
  • classification, and
  • post-approval submissions.

Updates are also being drafted of OCP's: 

  • 2005 guidance on "How to Write a Request for Designation," and 
  • 2006 guidance on "Considerations for Innovative Combination Products." 

Also expected to emerge from the agency`s pipeline this year are final regulations for combination product GMPs and for CP post-market safety reporting requirements.

OCP Deputy Director Patricia Love highlighted her office's current initiatives at a "CMC Workshop" co-sponsored by the Drug Information Association (DIA) and the American Association of Pharmaceutical Scientists (AAPS) in Washington, D.C. in February.
Love addressed a session of the workshop focused on regulatory issues for combination products in the U.S., Europe and Japan. She provided the participants with an overview of the current FDA CP regulatory process and offered advice on how firms should engage with it. Her talk encompassed: 

  • definitions and assignments 
  • development and clinical trials 
  • the marketing application process 
  • GMPs and inspections 
  • post-approval changes, and 
  • OCP regulatory initiatives.

To read the complete story, please see the ECA website members' area.

Source: This article is taken from the IPQ (International Pharmaceutical Quality Journal).
IPQ's monthly format keeps subscribers "Inside the Global Regulatory Dialogue"™ where the initiatives are being defined that will reshape the landscape. The IPQ is one of the most important Journals in the GMP and regulatory environment. In co-operation with IPQ the ECA publishes selected articles in the members' area on the ECA website. Members also benefit from a special agreement with IPQ´s Editor in Chief Bill Paulson: an exclusive subscription fee for the IPQ Journal. You will find more information in the members' area.

To find out more about IPQ, please visit the IPQ website.

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