FDA PUBLIC MEETING

DRAFT GUIDANCE FOR INDUSTRY:
DEVELOPING MEDICAL IMAGING DRUGS AND BIOLOGICS

5630 Fishers Lane, Room 1066
Rockville, MD 20852
March 26, 1999
8:30 am - 4:00 pm

AGENDA

I. INTRODUCTORY REMARKS

FDA
Council on Radionuclides and Radiopharmaceuticals (CORAR)
Medical Imaging Contrast Agent Association (MICAA)

II. GROUP 1

1. FDA Intent of Group 1 and Update
   
   
2. RADIOPHARMACEUTICAL ISSUES
   (CORAR Perspectives)

1. Nonclinical Group 1 Entry Criteria
   Rationale & Definition of NOUEL Terminology
   Pharmacology/Toxicology Animal Studies
   Pharmacokinetics, Pharmacodynamics
   
   
2. Clinical Trial Information
   Pharmacokinetics, Pharmacodynamics
   Clinical Monitoring in Phase 1, 2 & 3

3. CONTRAST DRUGS
   (MICAA Perspectives)

1. Nonclinical Group 1 Entry Criteria
   Rationale & Definition of NOUEL Terminology
   Pharmacology/Toxicology Animal Studies
   Pharmacokinetics, Pharmacodynamics

2. Clinical Trial Information
   Pharmacokinetics, Pharmacodynamics
   Clinical Monitoring in Phase 1, 2 & 3

III. BLINDED READING

1. FDA Update
   
   
2. Industry Comments
   Use of fully informed blinded reads or on site image interpretation in the package insert

IV. INDICATIONS AND CLINICAL DESIGN DISCUSSION

1. FDA Update
   
   
2. Industry Comments

1. Indication Categories
2. Clinical Benefit / Utility
3. Comparators
4. Standard of Truth

V. OPEN COMMENT

VI. ADJOURN

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