Description
This guidance provides recommendations to industry on the development of a shared system risk evaluation and mitigation strategy (REMS)2 16 for multiple prescription drug (including biological) products. This guidance describes some of the possible benefits of a shared system REMS, and provides general principles and recommendations to assist industry with the development of these programs. This guidance does not discuss the process for requesting a waiver of the single, shared system REMS requirement that applies to abbreviated new drug applications (ANDAs) referencing a listed drug with an approved REMS. FDA issued a separate guidance describing the process for requesting waivers and the criteria FDA applies in considering them.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1Reference Listed Drug used as the basis for an ANDA submission.
Stakeholders
7Entity submitting development data and knowledge; Entity performing the work process for change
Group formed to develop a shared system REMS
The applicant for the RLD
Representative for the IWG in communication with FDA
Aids in implementation and management of the program
new facilities added by the DMF holder
holders of approved NDAs, BLAs, and ANDAs
Regulatory Context
Regulatory Activities
7Abbreviated New Drug Application
New Drug Application
ANDA submission containing a waiver request
Rule does not apply to products marketed under an NDA
BLA for biological products
Notification that an ANDA meets requirements but cannot be approved due to patents or exclusivity.
Changes to an existing REMS requiring approval
Document Types
5Submission mechanism for shared system REMS; A DMF used for shared system REMS submissions to improve efficiency.
FDA-approved patient labeling
also known as Patient Information
Expands on information in the REMS document; The REMS supporting document should expand on information in the REMS document.
Technical guide providing detailed submission instructions.
Attributes
2Information that triggers the authority to require PMRs
Similar risks for a class of products
Technical Details
Testing Methods
1Periodic evaluations to determine if REMS goals are met
Standards & References
External Standards
1Section 351 of the Public Health Service Act for biologics
Related CFR Sections (2)
- 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 →
- 21CFR314.107§ 314.107 Date of approval of a 505(b)(2) application or ANDA.
(a) General. A drug product may be introduced or delivered for introduction into interstate commerce when the 505(b)(2) application or ANDA for the drug product is approved. A 505(b)(2) application or ANDA for a drug product is approved on the date FDA issues an approval letter under § 314.105 for tRead full regulation →
See Also (8)
- Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (Status: Draft)
- Formas posológicas orales sólidas de liberación inmediata Cambios de escala y posteriores a la aprobación: documentación química, de fabricación y controles, de pruebas de disolución in vitro y bioequivalencia in vivo. (Status: Final)
- SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (Status: Final)
- SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation: Guidance for Industry (Status: Final)
- Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (Status: Final)
- SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation: Guidance for Industry (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Drug Master Files for Bulk Antibiotic Drug Substances: Guidance for Industry (Status: Final)