Description
Nanotechnology can be used in a broad array of FDA-regulated products, such as humandrug products, including those that arebiological products.3Nanotechnology may be used to create drug products in whichnanomaterials(as explained in section II of this document), serve a variety of functions, as active ingredients4orinactive ingredients, includingcarriersloaded with an active ingredient. The inclusion of such materials may result in product attributes that differ from those of products that do not contain such materials, and thus may merit particular examination. This document provides guidance on the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form.
Scope & Applicability
Product Classes
7Requires analytical comparability per ICH Q5E
RTRT and CTD sections apply to drug products
General category of products addressed by the guidance; General category of products discussed in the guidance
Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Nonprescription drug products marketed without product-specific premarket application
A type of ATMP involving recombinant nucleic acids or viral vectors.
Stakeholders
3Group that prepared the guidance
Entity responsible for submitting applications under section 524B
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
10Methods for characterizing nanomaterials
Size range of approximately 1 to 100 nm
The core requirement for ANDA approval relative to the RLD
Used to determine the priority of establishments for inspection.
Pharmacokinetic-pharmacodynamic relationship
Biological property that may be altered by manufacturing changes; safety narrative should address bioavailability of the ingredients
Inherent property of some nanomaterials impacting quality risk
Surface charge attribute impacting stability
Specific CQA for a nanomaterial.
Critical attribute impacting bioequivalence of locally acting TAMAs.
Identified Hazards
Hazards
2Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces
Safety concern if product heterogeneity is inconsistent
Related CFR Sections (9)
- 21CFR314.420§ 314.420 Drug master files.
(a) A drug master file is a submission of information to the Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigationalRead full regulation →
- 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 →
- 21CFR320.21§ 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 →
- 21CFR314.3§ 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 →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR330.1§ 330.1 General conditions for general recognition as safe, effective and not misbranded.
An over-the-counter (OTC) drug listed in this subchapter is generally recognized as safe and effective and is not misbranded if it meets each of the conditions contained in this part and each of the conditions contained in any applicable monograph. Any product which fails to conform to each of the cRead full regulation →
- 21CFR211.22§ 211.22 Responsibilities of quality control unit.
(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no eRead full regulation →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read 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 →
Related Warning Letters (10)
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Medinatura New Mexico, Inc.
- 2025-12-16
CGMP/Positron Emission Tomography (PET) Drugs/Adulterated
3D Imaging Drug Design and Development LLC
- 2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
CDL Services, Inc. DBA Technichem
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
Seaway Pharma Inc.
See Also (8)
- CVM GFI #57 Preparation and Submission of Veterinary Master Files (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Drug Master Files for Bulk Antibiotic Drug Substances: Guidance for Industry (Status: Final)
- Early Development Considerations for Innovative Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (Status: Final)
- IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry and FDA Staff (Status: Final)
- Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry (Status: Final)
- Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry (Status: Draft)