Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Controlled Correspondence Related to Generic Drug Development.” This guidance 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. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA’s controlled correspondence response and the Agency’s process for responding to those requests. This guidance finalizes the draft guidance of the same title issued on December 22, 2022. This guidance replaces the guidance “Controlled Correspondence Related to Generic Drug Development” issued on December 17, 2020.
Scope & Applicability
Product Classes
7topic of the guidance document
Injectable products subject to specific inactive ingredient rules.
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Requests related to the evaluation of the user interface; Products consisting of both a drug and a device constituent part.
Products with complex active ingredients or formulations
The drug product identified by the applicant for comparison; Comparison of ANDA product to RLD for pH adjuster differences
Reference Listed Drug used as the basis for an ANDA submission.
Stakeholders
5Entities that can submit controlled correspondence
Person authorized to submit requests on behalf of the manufacturer.
Any person or group of persons marketing, manufacturing, processing, or developing a drug; Entity maintaining information for demonstrations of safety and effectiveness
Entities that can submit controlled correspondence on behalf of manufacturers
Entity submitting correspondence; Entities eligible to submit controlled correspondence.; Entity that may submit requests for clarification.
Regulatory Context
Attributes
6Standard controlled correspondence with a 60-day goal; Classification of the inquiry used to calculate the goal date.
factor used to prioritize evaluation of at-risk drug products; Used to calculate concentration limits in ppm
Qualitative and quantitative equivalence to the RLD; Qualitative and quantitative formulation sameness for complex products.
The physical form of the drug product.
Complex controlled correspondence with a 120-day goal; Classification of the inquiry used to calculate the goal date.
FDA performance metric for responding to submissions; The date by which FDA intends to respond to the controlled correspondence.
Identified Hazards
Hazards
1Safety concerns linked to inadequate servicing or remanufacturing
Related CFR Sections (4)
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
- 21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
See Also (8)
- Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (Status: Draft)
- Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting: Guidance for Industry (Status: Final)
- Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route (Status: Final)
- Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry (Status: Draft)
- Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products (Status: Draft)
- Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples: Draft Guidance for Industry (Status: Draft)
- Migraine: Developing Drugs for Preventive Treatment (Status: Draft)
- Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022 (Status: Final)