Description
This guidance is intended to provide information to applicants on certain specific variations of a drug product that should be included in a single abbreviated new drug application (ANDA) and describe the general factors to be considered when determining whether single or multiple ANDAs should be submitted.
Scope & Applicability
Product Classes
5Sterile preparations for dispensing single doses to many patients in a pharmacy admixture program.
UVB-induced phototoxicity is more relevant for topical products
Drug products delivered through the skin; Patch-based delivery systems
Products requiring visual inspection for particulate matter
Subject of the minor changes guidance
Stakeholders
1Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
4Reference Listed Drug used as the comparator in bioequivalence studies.
Property maintained by inactive ingredients in parenteral formulations
Field B.2.2.2 describing the physical form of the VMP
controls in place to maintain the strength, composition, and purity
Related CFR Sections (1)
- 21CFR320.22§ 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
(a) Any person submitting a full or abbreviated new drug application, or a supplemental application proposing any of the changes set forth in § 320.21(c) , may request FDA to waive the requirement for the submission of evidence measuring the in vivo bioavailability or demonstrating the in vivo bioeqRead full regulation →
See Also (8)
- Guía para la Industria: Pruebas de disolución de formas de dosificación oral sólidas de liberación inmediata. (Status: Final)
- Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Status: Final)
- Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing (Status: Final)
- Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for Industry (Status: Final)
- Final In Vivo Bioavailability-Bioequivalence Studies- Analytical (Status: Final)
- Topical Dermatologic Corticosteroids: in Vivo Bioequivalence (Status: Final)
- Bioresearch Monitoring Technical Conformance Guide (Status: Final)
- Data Integrity for In Vivo Bioavailability and Bioequivalence Studies (Status: Draft)