Controlled correspondence

16
Dec

OGD Finalizes Controlled Correspondence Guidance

While many in the industry have complained about the handling of controlled correspondences (CCs), the numbers of CCs submitted in a given month continues to rise as it has every fiscal year since the process was formalized under GDUFA I.  Complaints of non-answers to questions, unclear answers, and just flat-out denials of acceptance of CCs […]

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06
Nov
Audience Perspective Image

Audience Perspective – Both Sides of the Controlled Correspondence Story; One Common Problem

At the Association for Accessible Medicines GRx-Biosims conference currently ongoing in Bethesda, members of the FDA and industry came together to present opinions and discuss the Controlled Correspondence process.  Controlled Correspondence (CC) between the FDA and industry is very much like an important pen pal relationship (where you only write to each other regularly, but […]

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