Description
This guidance provides recommendations to you, manufacturers, sponsors, and clinical investigators involved in the clinical studies of allogeneic pancreatic islet cell products for the treatment of Type 1 diabetes mellitus. We, FDA, are issuing this guidance to assist you by identifying data and information obtained during investigational new drug (IND) studies that might be helpful in establishing the safety, purity, and potency of a biological product. This guidance is not intended to identify all of the product, preclinical, and clinical data that might be needed to successfully support a biologics license application (BLA). This guidance finalizes the draft guidance of the same title, dated May 2008.
Scope & Applicability
Product Classes
1Guidance provides recommendations for manufacturers and sponsors of these products.; Main subject of the guidance regarding considerations for development and clinical trials.; Considerations for Allogeneic Pancreatic Islet Cell Products
Stakeholders
3Entity responsible for harvesting and delivering organs for manufacturing.
Team responsible for intensive diabetes management prior to enrollment.
Administrative structure reviewing trial data
Regulatory Context
Attributes
3Parameter to be collected regarding organ harvesting.
primary analyses of all outcomes should be performed on an intent-to-treat (ITT) population
expressed as kilograms of weight divided by height in meters squared (kg/m²); percentage change in body weight equals percentage change in BMI
Related CFR Sections (3)
- 21CFR211.113§ 211.113 Control of microbiological contamination.
(a) Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.Read full regulation →
- 21CFR312.32§ 312.32 IND safety reporting.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR50.25§ 50.25 Elements of informed consent.
(a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:Read full regulation →
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See Also (8)
- Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications (Status: Final)
- CPG Sec. 430.200 Repacking of Drug Products - Testing/Examination under CGMPs (Status: Final)
- CPG Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs (Status: Final)
- CPG Sec. 410.100 *Finished Dosage Form Drug Products in Bulk Containers - Applications of Current Good Manufacturing Practice Regulations* (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)
- Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical Studies (Status: Final)
- Preparation of Investigational New Drug Products (Human and Animal): Guidance for Industry (Status: Final)
- Review of FDA's Implementation of the Drug Export Amendments of 1986 (Status: Final)