Description
This guidance discusses what types of information you, the applicant, should submit in your new drug application (NDA) or abbreviated new drug application (ANDA) for a liposome drug product reviewed by the Center for Drug Evaluation and Research (CDER). The discussion addresses the following topics for liposome drug products: (A) chemistry, manufacturing, and controls (CMC); (B) human pharmacokinetics and bioavailability or, in the case of an ANDA, bioequivalence; and (C) labeling in NDAs and ANDAs.
Scope & Applicability
Product Classes
2specific product type mentioned in table of contents; Specific guidance for dosage and administration
Substitution recommendations
Stakeholders
1Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
7Physical, chemical, biological, or microbiological properties
determination by FDA regarding substitution
Molar ratio of each individual lipid to the drug substance.
Physicochemical property including lamellarity determination.
Surface charge attribute impacting stability
Physical property of drug substance affecting manufacturability
Physicochemical parameters of the liposome determined to be the CQAs.
Identified Hazards
Hazards
3risk of febrile reaction addressed by pyrogenicity testing
potential cause of product failure in sustained-release dosage forms
Lipids with unsaturated fatty acids are subject to oxidative degradation.
Related CFR Sections (5)
- 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 →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
- 21CFR299.4§ 299.4 Established names for drugs.
(a) Section 508 of the Federal Food, Drug, and Cosmetic Act (added by the Kefauver-Harris Drug Amendments of 1962; Pub. L. 87-781) authorizes the Commissioner of Food and Drugs to designate an official name for any drug if he determines that such action is necessary or desirable in the interest of uRead full regulation →
- 21CFR320.21§ 320.21 Requirements for submission of bioavailability and bioequivalence data.
(a) Any person submitting a full new drug application to the Food and Drug Administration (FDA) shall include in the application either:Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
See Also (8)
- Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Status: Draft)
- Individual Product Bioequivalence Recommendations for Specific Products (Status: Final)
- PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (Status: Final)
- FDA Oversight of PET Drug Products -- Questions and Answers (Status: Final)
- Referencing Approved Drug Products in ANDA Submissions Guidance for Industry (Status: Final)
- Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA: Guidance for Industry (Status: Final)
- Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry (Status: Final)
- Contents of a Complete Submission for the Evaluation of Proprietary Names (Status: Final)