Controlled Correspondence Related to Generic Drug Development
A controlled correspondence is a communication 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.
- Background
- Guidance for Industry
- Submitting Controlled Correspondence
- Related Resources
- Contact Information
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 III).
Level 1 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: (a) before abbreviated new drug application (ANDA) submission, (b) after a product-specific guidance teleconference if a prospective applicant or applicant seeks further feedback from FDA, (c) after issuance of a complete response letter (CRL) or tentative approval, or (d) after ANDA approval. Level 1 controlled correspondence is also correspondence concerning post-approval submission requirements that are not covered by Center for Drug Evaluation and Research (CDER) post-approval changes guidance and are not specific to an ANDA. Pursuant to the GDUFA II Commitment Letter, FDA will review and respond to 90 percent of Level 1 controlled correspondence within 60 calendar days of the date of submission.
Level 2 controlled correspondence is correspondence that meets the definition of lLevel 1 controlled correspondence and (a) involves evaluation of clinical content, (b) requests a Covered Product Authorization (CPA) and review of bioequivalence (BE) protocols for development and testing that involves human clinical trials for an ANDA where the reference listed drug (RLD) is subject to a Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU), (c) requests a CPA to obtain sufficient quantities of an individual covered product subject to a REMS with ETASU when development and testing does not involve clinical trials , (d) requests evaluations of alternative BE approaches (e.g., pharmacokinetic, in vitro, clinical, or (e) requires input from another office or center. Pursuant to the GDUFA II Commitment Letter, FDA will review and respond to 90 percent of Level 2 controlled correspondence within 120 calendar days of the date of submission.
Controlled Correspondence Guidance for Industry
An important resource for generic drug manufacturers and related industry is the 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, last updated in March 2024, also describes FDA’s process for providing communications related to such correspondence.
Submitting Controlled 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. For additional support, you can contact CDER Platform Support at edmsupport@fda.hhs.gov.
- Final Guidance for Industry: Controlled Correspondence Related to Generic Drug Development (March 2024)
- GDUFA III Commitment Letter (PDF)
For questions regarding controlled correspondence that are not covered by FDA’s guidance on this topic, please direct them to the Controlled Correspondence Coordinators at GenericDrugs@fda.hhs.gov.