For Industry

FDA posts Final Guidance for Industry: Controlled Correspondence Related to Generic Drug Development

A controlled correspondence is a correspondence submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element of generic drug product development or certain postapproval submission requirements.

CDER Direct NextGen Collaboration Portal

Background

Generic drug manufacturers and related industry can submit written inquiries to the Office of Generic Drugs (OGD) that are referred to as controlled correspondence. These are requests for information on a specific element of generic drug development or certain postapproval submission requirements. FDA and industry agreed to timelines for the review of controlled correspondence under the reauthorization of the Generic Drug User Fee Amendments (GDUFA II). Effective October 2018, the Agency is providing a new path for generic drug manufacturers and related industry (or their authorized representatives) to submit controlled correspondence via the CDER Direct NextGen Collaboration Portal.

Standard controlled correspondence is correspondence submitted to the Agency, by or on behalf of a generic drug manufacturer or related industry, requesting information on a specific element of generic drug product development. Standard controlled correspondence is also correspondence concerning post-approval submission requirements that are not covered by CDER post-approval changes guidance and are not specific to an abbreviated new drug application (ANDA). Pursuant to the GDUFA II Commitment Letter, FDA agreed to review and respond to 90 percent of standard controlled correspondence within 60 calendar days of the date of submission.

Complex controlled correspondence is correspondence involving: (1) evaluation of clinical content, (2) review of bioequivalence (BE) protocols for reference listed drugs (RLDs) with risk evaluation and mitigation strategies (REMS) with elements to assure safe use (ETASU), or (3) requested evaluations of alternative BE approaches within the same study type (e.g., pharmacokinetic, in vitro, clinical). Pursuant to the GDUFA II Commitment Letter, FDA will review and respond to 90 percent of complex controlled correspondence within 120 calendar days of the date of submission.

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Controlled Correspondence Guidance for Industry

An important resource for generic drug manufacturers and related industry is the final guidance for industry, Controlled Correspondence Related to Generic Drug Development, which provides detailed information regarding the process by which controlled correspondence can be submitted to FDA requesting information related to generic drug development. This guidance also describes FDA’s process for providing communications related to such correspondence. 

Submitting Controlled Correspondence

Starting October 1, 2018, generic drug manufacturers and related industry (or their authorized representatives) will be able to submit their controlled correspondence via the CDER Direct NextGen Collaboration Portal. To register for an account with the CDER Direct NextGen Collaboration Portal, navigate to https://edm.fda.gov. Under the ‘Login’ section on the right of the screen, click on ‘New User’. On the ‘Request a Login’ page, check the ‘Controlled Correspondence’ event and provide all pertinent information such as contact information, organization information, and security questions. After submitting, your request will be validated, and you will receive an email with a confirmation/activation link.

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Resource

A pre-recorded webinar explaining the draft guidance is available: Webinar - Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development.

Contact Information

For questions regarding submitting a controlled correspondence or regarding an assigned controlled correspondence, please direct it to the Controlled Correspondence Coordinators at GenericDrugs@fda.hhs.gov.

If you would like to receive news and information regarding GDUFA and/or Generic Drugs, you may sign up for email updates.
 

 

Page Last Updated: 10/03/2018
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