Description
This guidance describes FDA’s process for making available to the public FDA guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs will be able to access BE study guidance on the FDA Web site, rather than having to request this information from the Agency and wait for the Agency to respond, as has been the case in the past. The FDA believes that making this information available on the Internet will streamline the guidance process, making it more efficient than the previous process. This process also will provide a meaningful opportunity for the public to consider and comment on BE study recommendations for specific drug products.
Scope & Applicability
Product Classes
4UVB-induced phototoxicity is more relevant for topical products
Products that may pose complex bioequivalence issues
The drug product identified by the applicant for comparison; Comparison of ANDA product to RLD for pH adjuster differences
Drug products referencing a reference listed drug; Proposed products seeking approval via ANDA.
Stakeholders
2Entities involved in bioresearch monitoring compliance
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
1Parameters used to measure bioequivalence for drugs in the bloodstream
Related CFR Sections (3)
- 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 →
- 21CFR320.24§ 320.24 Types of evidence to measure bioavailability or establish bioequivalence.
(a) Bioavailability may be measured or bioequivalence may be demonstrated by several in vivo and in vitro methods. FDA may require in vivo or in vitro testing, or both, to measure the bioavailability of a drug product or establish the bioequivalence of specific drug products. Information on bioequivRead full regulation →
- 21CFR320.1§ 320.1 Definitions.
The definitions contained in § 314.3 of this chapter apply to those terms when used in this part.Read full regulation →
See Also (8)
- ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions (Status: Final)
- Guía para la Industria: Pruebas de disolución de formas de dosificación oral sólidas de liberación inmediata. (Status: Final)
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)
- Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Status: Final)
- Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability (Status: Final)
- Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Status: Draft)
- Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs (Status: Final)
- Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry (Status: Draft)