Dear Ogesh
I presume you refer to a design space as defined in ICH Q8. There is, to my knowledge no precedence yet, nor is there clarity what the agencies, including FDA will require.
It may be necessary to consult with the agency on a case by case basis
In theory (not in praxis) any change within the design space should be allowed and not require prior or post approval by an agency
Siegfried
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Siegfried Schmitt
Principal Consultant
PAREXEL
Braintree, Essex
United Kingdom
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Original Message:
Sent: 05-05-2014 08:30
From: Y Ogesh Patel
Subject: Post approval changes
Hello,
Studying for Global Scope RAPS exam. What would be a classification of changes if there is a change in design space of my DS/DP of an approved NDA or ANDA? . What measures should company take for major or minor post approval changes in design space?
Regards,
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Y Ogesh Patel MS
Clifton NJ
United States
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