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          CDER and CBER accept first submission to ISTAND Pilot ProgramDrug Safety and Availability CDER and CBER accept first submission to ISTAND Pilot Program
  
  	
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    Print**[9/7/2022]** FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have accepted the agency’s first submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program.

FDA launched ISTAND in 2020 to support development of drug development tools (DDTs) that are considered novel to be used in regulatory applications for new medical products.

DDTs are methods, materials or measures that can facilitate drug development. Certain DDTs, such as biomarkers and clinical outcome assessments, have clearly established pathways for evaluation and application. ISTAND opens additional opportunities for unconventional approaches to be reviewed and accepted by FDA. If qualified, these tools can help optimize drug development and evaluation, potentially expediting the availability of safe and effective drug and biologic products.

ISTAND’s first accepted Letter of Intent (LOI) submission is for a tool that proposes to evaluate off-target protein binding for a variety of biotherapeutic modalities, potentially reducing or eliminating the need to conduct some of the more standard nonclinical toxicology tests. The tool’s developers hope it will improve the accuracy, sensitivity and overall utility of specificity testing of biotherapeutics to support investigational new drug applications.

The LOI acceptance is the first step of the three-step qualification process in the DDT qualification programs, and it is based on several factors, including the scientific merit of the submission, the ability of the DDT to address a specified drug development need, the availability of information and resources that support the proposed qualification effort and demonstration that the DDT is feasible and practical within the proposed context of use. FDA will now work with the applicant to provide feedback on the next qualification step—a qualification plan.

CDER and CBER are excited to kickstart the future of novel DDT development with the first ISTAND LOI acceptance. We look forward to ISTAND’s continued support of innovative approaches to drug development and to the program’s contributions to bringing effective therapies to patients faster.

For more information:

CDER Conversation: CDER Focuses on Novel Drug Development Tools to Help Speed Creation of New Therapies
	ISTAND Pilot Program Submission Process
	DDT Qualification Programs
	CDER & CBER Drug Development Tool Qualification Project Search

                                                                                  Content current as of:
      09/07/2022
              
              
Regulated Product(s)
		 DrugsDrug Safety and Availability

          
                        Drug Alerts and Statements
          Information about Nitrosamine Impurities in Medications
          Medication Guides
          Drug Safety Communications


                        Food and Drug Administration Overdose Prevention Framework
          Drug Shortages
          FDA Drug Safety Podcasts
          Information by Drug Class
          Medication Errors Related to CDER-Regulated Drug Products
          Postmarket Drug Safety Information for Patients and Providers
          Risk Evaluation and Mitigation Strategies | REMS
          Safe Use Initiative
          Drug Recalls
          Drug Supply Chain Integrity
          Multistate outbreak of fungal meningitis and other infections
 
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