Description
The purpose of this guidance is to assist sponsors in the development of drugs for the treatment or prevention of neglected tropical diseases (NTDs) of the developing world. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall drug development program for the treatment or prevention of NTDs, as defined in section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including clinical trial designs and internal review standards to support approval of drugs.
Scope & Applicability
Product Classes
3Drugs for treatment or prevention of NTDs
In vitro studies used to determine PD characteristics like susceptibility.
Defined as an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections.
Stakeholders
3Entity responsible for submitting applications under section 524B
Entities submitting supplements to BLAs
Assist sponsors in the nonclinical evaluation
Regulatory Context
Attributes
1Relevant characteristic of the study population
Related CFR Sections (8)
- 21CFR314.105§ 314.105 Approval of an NDA and an ANDA.
(a) FDA will approve an NDA and send the applicant an approval letter if none of the reasons in § 314.125 for refusing to approve the NDA applies. FDA will issue a tentative approval letter if an NDA otherwise meets the requirements for approval under the Federal Food, Drug, and Cosmetic Act, but caRead full regulation →
- 21CFR312.84§ 312.84 Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
(a) FDA's application of the statutory standards for marketing approval shall recognize the need for a medical risk-benefit judgment in making the final decision on approvability. As part of this evaluation, consistent with the statement of purpose in § 312.80 , FDA will consider whether the benefitRead full regulation →
- 21CFR312.23§ 312.23 IND content and format.
(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →
- 21CFR312.120§ 312.120 Foreign clinical studies not conducted under an IND.
(a) Acceptance of studies.Read full regulation →
- 21CFR314.106§ 314.106 Foreign data.
(a) General. The acceptance of foreign data in an application generally is governed by § 312.120 of this chapter .Read full regulation →
- 21CFR314.126§ 314.126 Adequate and well-controlled studies.
(a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been develRead full regulation →
- 21CFR314.600§ 314.600 Scope.
This subpart applies to certain new drug products that have been studied for their safety and efficacy in ameliorating or preventing serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological, chemical, radiological, or nuclear substances. This subpRead full regulation →
- 21CFR601.90§ 601.90 Scope.
This subpart applies to certain biological products that have been studied for their safety and efficacy in ameliorating or preventing serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological, chemical, radiological, or nuclear substances. This suRead full regulation →
See Also (8)
- Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products (Status: Draft)
- Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 : Guidance for Industry (Status: Final)
- Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief (Status: Draft)
- Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications (Status: Final)
- Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs) (PDF) (Status: Final)
- Study of Sex Differences in the Clinical Evaluation of Medical Products (Status: Draft)
- Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products: Guidance for Industry (Status: Final)
- Study Data Technical Conformance Guide - Technical Specifications Document (Status: Final)