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USFDA Guidance: Controlled Correspondence Related to Generic Drug Development

On 18th March, 2024 the U.S. Food and Drug Administration (FDA) the Center for Drug Evaluation and Research released the final guidance "Controlled Correspondence Related to Generic Drug Development" which provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency’s process for providing communications related to such correspondence.

Controlled correspondence refers to written communications between a regulated company and a regulatory agency that are related to specific regulatory questions or issues. These communications are considered "controlled" because they are subject to specific regulations and guidelines regarding their content, format, and handling.

This guidance provides additional detail and recommendations concerning:

  • What inquiries FDA considers to be controlled correspondence for the purposes of meeting the Agency’s agreements under the GDUFA III commitment letter

  • What information requestors should include in a controlled correspondence to facilitate FDA’s consideration of and response to a controlled correspondence

  • What information FDA will provide in its communications to requestors that have submitted controlled correspondence

  • How requestors can submit requests to clarify ambiguities in FDA’s controlled correspondence responses and the Agency’s process for responding to those requests.

A controlled correspondence can be submitted by or on behalf of a generic drug manufacturer or related industry before ANDA submission. The following information should be included in the controlled correspondence:

  • Application holder

  • Application number

  • Proprietary name

  • Active ingredient

  • Strength

  • If a parenteral drug product, specify the fill volume

  • Dosage form

  • Route of administration

  • Approval date

  • Marketing status

The scope of the clarifying questions should be limited to the content of the FDA’s controlled correspondence response. Any requests to review follow-up questions or new or additional information will be considered a new controlled correspondence. Click this LINK to know more in details about How To Submit a Controlled Correspondence.

Also, check out the final guidance "Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing" which provides sponsors with guidance on when and how to conduct studies to determine whether renal impairment influences an investigational drug's pharmacokinetics. It provides recommendations on the design and implementation of such studies, when they should be conducted, and how to assess renal impairment's influence on an investigational drug's pharmacokinetics.


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