Controlled correspondence


Revised Guidance on Controlled Correspondence for ANDAs

The FDA published a revised guidance issue today (here) that revises a December 2020 guidance on Controlled Correspondence (CC) by the Office of Generic Drugs.  This December 2020 guidance is being updated to reflect the new provisions of GDUFA III and its commitment letter relative to the submission of CC. “This guidance provides information regarding the […]

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Examples of Many of the Catch 22s of Controlled Correspondence with the FDA

Okay, so you want to bring a product back from the dead.  That is, you want to file an ANDA for an older discontinued product without competition and with no designated reference listed drug (RLD) or reference standard (RS) published in the Orange Book (OB).  Oh yeah, and you also want to start a development […]

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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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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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