Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients | Guideline Explorer

Description

This document provides guidance concerning development of safety profiles to support use of new excipients as components of drug or biological products. It is intended for use by reviewers within both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and by interested individuals in industry. It is also intended to foster and expedite the development of new excipients, communicate to pharmaceutical and excipient manufacturers current CDER and CBER recommendations on the nonclinical safety data that should be generated to support excipient development, and increase uniformity within CDER and CBER as to expectations for the nonclinical safety evaluation of excipients.

Scope & Applicability

Product Classes

5

Over-the-Counter Products

OTC drug products requiring safety evaluation

ophthalmic products

Products requiring ocular irritation studies

topical dermal products

Products requiring ocular irritation studies

Generic Products

Generic drug products requiring safety evaluation; Drug products submitted via ANDA

OTC drug

Nonprescription human drug products marketed without an approved application.

Stakeholders

2

Manufacturer

Entity responsible for submitting NDINs

Sponsor

Entity responsible for submitting applications under section 524B

Regulatory Context

Attributes

2

Duration of exposure

The period during which the exposure is having its effect

Maximum Feasible Dose

Dose selection endpoint

Identified Hazards

Hazards

1

Toxicants

Potentially harmful components that may increase due to genetic modifications.

Related CFR Sections (2)

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 →
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 →

Related Warning Letters (10)

Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated/Failure to Register and List
Jose Miguel Gutierrez Salas
2022-07-26
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Noticias Mexico Hoy Grupo Multimedia, S.A. de C.V.
2022-07-12
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ATLRx, Inc.
2022-05-04
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Rena's Organic
2022-05-03
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Limpo Quimicos, SA de CV
2021-10-05
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Tropicosmeticos SA de CV
2021-08-17
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
MB Solutions, LLC/BioSpectrum CBD
2021-07-29
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Incredible Products, SA de CV
2021-06-01
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Neoingenium Labs, SA de CV
2021-04-06
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V.
2021-03-02