The tables below list information about submissions to the FDA Clinical Outcome Assessments (COA) Qualification Program for which final COA qualification determinations have not yet been made. The tables include legacy projects (those submitted prior to enactment of the 21st Century Cures Act), as well as those submitted as part of the newer section 507 process (referring to section 507 of the Federal Food, Drug and Cosmetic Act (FD&C Act), which was created by Section 3011 of the 21st Century Cures Act). These tables only include documents from requestors that were received after the passage of the 21st Century Cures Act. The tables are updated on a biannual basis and provide information on the COA qualification project, including FDA’s decision to accept or not accept the submission, and FDA’s recommendations on further COA development.
FDA’s posting of information submitted to the Agency by outside parties requesting qualification of a drug development tool is not an endorsement or recommendation by FDA of the tool’s use. Information about submissions is made publicly available in accordance with section 507 of the FD&C Act. The FDA makes no representations, guarantees, or warranties as to the accuracy, completeness, currency, or suitability of the information in submissions. See the FDA decision letter corresponding to each submission for FDA considerations and recommendations related to each request for qualification.
To view qualified COAs, please visit: Qualified Clinical Outcome Assessments (COAs).
Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)
Division of Cardiology and Nephrology (DCN)
*Under review prior to the passage of the 21st Century Cures Act
Division of General Endocrinology (DGE)
Division of Nonmalignant Hematology (DNH)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type |
Qualification Stage |
|---|---|---|---|---|---|
| Sickle Cell Disease (SCD) | DDT COA #000057: Sickle Cell Pain Diary | Pain intensity and pain interference | Pediatric patients with SCD | PRO | Letter of Intent- Accepted |
Division of Diabetes, Lipid Disorders, and Obesity (DDLO)
Office of Neuroscience (ON)
Division of Neurology I (DNI)
Division of Neurology II (DN II)
Division of Psychiatry (DP)
Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP)
Office of Immunology and Inflammation (OII)
Division of Rheumatology and Transplant Medicine (DRTM)
Division of Pulmonary, Allergy, and Critical Care (DPACC)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type |
Qualification Stage |
|---|---|---|---|---|---|
| Asthma | DDT COA #000099: Child Asthma Diary (CAD) | Symptom severity | Children (4-11 years) with a clinical diagnosis of mild to severe persistent asthma requiring a daily long-term control medication | PRO/ObsRO | Letter of Intent- Accepted |
| Chronic Obstructive Pulmonary Disease (COPD) | DDT COA #000072: Constant Work Rate Exercise | Exercise endurance |
COPD patients with moderate to very severe lung function impairment:
Current or ex-smokers with a smoking history of more than 10 pack-years. |
PerfO | Qualification Plan- Not Accepted |
| Chronic Obstructive Pulmonary Disease (COPD) | DDT COA #000125: Endurance Shuttle Walking Test (ESWT) | Walking endurance | COPD patients | PerfO | Qualification Plan- Not Accepted |
| Idiopathic pulmonary fibrosis (IPF) | DDT COA #000027: A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF) | Symptom experience, daily functioning and other health-related quality of life impacts | Adult patients (>18 years) with IPF | PRO | Letter of Intent- Accepted |
Division of Gastroenterology (DG)
Division of Hepatology and Nutrition (DHN)
Division of Dermatology and Dentistry (DDD)
Office of Infectious Diseases (OID):
Division of Anti-Infectives (DAI)
*Under review prior to the passage of the 21st Century Cures Act
Office of Oncologic Diseases (OOD)
Division of Oncology 1 (DO1)
Division of Oncology 2 (DO2)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type |
Qualification Stage |
|---|---|---|---|---|---|
| Small cell lung cancer (SCLC) | DDT COA #000133: Small Cell Lung Cancer PRO | SCLC symptom severity | Adult patients adults (>18 years) with clinician-confirmed diagnosis of limited or extensive stage SCLC with Eastern Cooperative Oncology Group performance status of 0 to 2, regardless of the lines of therapy being administered | PRO | Letter of Intent- Accepted |
Office of Specialty Medicine (OSM):
Division of Ophthalmology (DO)
| Disease/Condition | DDT COA Number and Instrument Name | Concept of Interest | Context of Use | COA Type | Qualification Stage |
|---|---|---|---|---|---|
| Retinitis Pigmentosa (RP) | DDT COA #000126: Functional Vision Questionnaire (FVQ) PRO | Visual function and functional vision | Adolescents (12-17 years) and adults (>18 years) with a clinical and genetic confirmed diagnosis of RP | PRO | Letter of Intent- Accepted |
| Retinitis Pigmentosa (RP) | DDT COA #000127: Functional Vision Questionnaire (FVQ) ObsRO | Visual function and functional vision | Pediatric (3-11 years) patients with a clinical and genetic confirmed diagnosis of RP | ObsRO | Letter of Intent- Accepted |
Resources
*Under review prior to the passage of the 21st Century Cures Act
