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.
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.
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.
Generic drug manufacturers and related industry (or their authorized representatives) can submit controlled correspondence via the CDER Direct NextGen Collaboration Portal. To register for an account, navigate to the CDER Direct NextGen Collaboration Portal, click “Sign Up” after “Don’t have an account?” and follow the instructions. For assistance with registering for the CDER NextGen Portal, please reference the user guides & FAQ’s here. For additional support, you can contact CDER Platform Support at email@example.com.
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A pre-recorded webinar explaining the draft guidance is available. Find it here.
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.