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FDA/Generic Communications Plan Restoring Best Of Past Practices

 
• By Derrick Gingery

Office of Generic Drugs wants to allow project managers to inform sponsors of major deficiencies before ‘complete response’ letter as part of ‘go/no go’ effort.

Generic sponsors may find some familiar practices in upcoming updates to the Office of Generic Drugs’ communications policy.

If in the ordinary course of business regulatory project managers learn of major deficiencies that would almost certainly derail an approval in the ANDAs they are shepherding through the review process, they will inform the sponsors

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