Description
This guidance provides recommendations for the nonclinical evaluation of previously approved drug substances when a new formulation or a new route of administration for a previously approved formulation is proposed by the sponsor. This guidance is intended for sponsors and review staff in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) involved in the development and review of new formulations of previously approved drug substances and proposals for existing formulations to be used by a new route of administration.
Scope & Applicability
Product Classes
2Guidance provides recommendations for the nonclinical evaluation of previously approved drug substances when a new formulation is proposed
Toxicity study of the proposed new formulation should be carried out
Stakeholders
2Entity responsible for submitting applications under section 524B
Assist sponsors in the nonclinical evaluation
Regulatory Context
Attributes
2measured by systemic availability of pharmaceutical-related substances
Biological property that may be altered by manufacturing changes; safety narrative should address bioavailability of the ingredients
Identified Hazards
Hazards
4Assessment of toxicity required in a 351(k) BLA
Risks to be understood when drug is developed for epidural route
Potential for allergic reaction to be evaluated for dermal, otic, and vaginal routes.
Potential toxicity requiring risk-minimization procedures like reducing light exposure.
Related CFR Sections (1)
- 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 →
Related Warning Letters (9)
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Sanitation & Environmental Technology Institute dba SDWH
- 2023-10-31
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Samm Solutions, Inc., d.b.a. BTS Research
- 2022-08-09
Bioresearch Monitoring Program
Valley Biosystems
- 2022-02-22
Good Laboratory Practice (GLP)
Toxikon Corporation/Labcorp Bedford LLC
- 2020-05-05
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
University of Kentucky
- 2020-04-07
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Steiner Biotechnology, LLC
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)
- 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)
- Controlled Correspondence Related to Generic Drug Development (Status: Final)
- Migraine: Developing Drugs for Preventive Treatment (Status: Draft)
- Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022 (Status: Final)