Description
This guidance is intended to describe the Office of Generic Drugs' (OGD) policy on the use of alternate sources of the active pharmaceutical ingredients (API) in unapproved abbreviated new drug applications (ANDAs). The guidance describes the circumstances under which an alternate source can be used. This guidance is intended to decrease the regulatory burden on industry and provide a more consistent approach to pre- and postapproval changes in API sources.
Scope & Applicability
Stakeholders
3Assigned from an Office of Health Technology as the primary point of contact.
Facility supplying raw materials or ingredients; Facility providing raw materials to a manufacturer
Entity submitting development data and knowledge; Entity performing the work process for change
Related CFR Sections (2)
- 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 →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
See Also (8)
- Food-Effect Bioavailability and Fed Bioequivalence Studies: Guidance for Industry (Status: Final)
- Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (Status: Final)
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators (Status: Final)
- ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for Industry (Status: Final)
- Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (Status: Draft)
- Evaluation of Therapeutic Equivalence (Status: Draft)
- Topical Dermatologic Corticosteroids: In Vivo Bioequivalence (Status: Draft)
- Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry (Status: Final)