Description
This guidance is intended to assist sponsors in the development of drug products for the treatment of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). This guidance focuses on specific drug development and trial design issues that are unique to the study of CFS/ME and on the FDA’s current thinking on how effective treatments can be developed for CFS/ME. The points discussed in this guidance may not be applicable to all drug products. The FDA encourages sponsors to design clinical programs that fit their particular needs and to discuss their planned approach with the Division of Pulmonary, Allergy, and Rheumatology Products.
Scope & Applicability
Product Classes
2Licensed under section 351 of the Public Health Service Act.
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.
Stakeholders
1The specific division within CDER responsible for implementing this guidance and discussing clinical programs.
Regulatory Context
Attributes
1Sponsors are encouraged to evaluate biomarkers relevant to the disease process
Related CFR Sections (2)
- 21CFR300.50§ 300.50 Fixed-combination prescription drugs for humans.
The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows: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 →
See Also (8)
- How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry (Status: Final)
- Development of New Stereoisomeric Drugs (Status: Final)
- Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)
- Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation (Status: Draft)
- Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (Status: Draft)
- Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (Status: Draft)
- Influenza: Developing Drugs for Treatment and/or Prophylaxis (Status: Final)
- Codevelopment of Two or More New Investigational Drugs for Use in Combination (Status: Final)