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      <PreparerPersonNm>CASEY T MIKESKA</PreparerPersonNm>
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      <PrimaryExemptPurposeTxt>THE COALITION OF PET DRUG MANUFACTURERS (CPDM) IS A VENUE FOR THE POSITRON EMISSION TOMOGRAPHY (PET) DRUG MANUFACTURING COMMUNITY TO ADVANCE SCIENTIFIC AND REGULATORY PRINCIPLES ASSOCIATED WITH THE MANUFACTURING OF PET DRUGS. THE KEY PURPOSES OF THIS MISSION ARE TO: PROVIDE A MULTI-STAKEHOLDER FORUM TO ADDRESS CURRENT TOPICS WITH GOVERNMENT AGENCIES AND OTHER GROUPS; ESTABLISH SCIENTIFICALLY SOUND AND RATIONAL PRACTICES FOR PET DRUG MANUFACTURING; PROVIDE EDUCATION AND TRAINING; ENABLE THE EXPANSION OF NEW PET DRUGS INTO ROUTINE MANUFACTURING NETWORKS; PROVIDE HIGH-VALUE RESOURCES TO ASSIST PET DRUG MANUFACTURERS WITH GMP COMPLIANCE AND INSPECTION CHALLENGES; ALIGN THE INTERESTS OF THE COMMUNITY OF PET DRUG MANUFACTURERS; AND TO ENGAGE IN ANY AND ALL LAWFUL ACTIVITIES TO ACCOMPLISH THE FOREGOING PRIMARY PURPOSE AND OBJECTIVES, EXCEPT AS RESTRICTED HEREIN.</PrimaryExemptPurposeTxt>
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        <DescriptionProgramSrvcAccomTxt>COALITION HELD OPEN BOARD MEETINGS ON AUGUST 15, 2022, NOVEMBER 14, 2022, MARCH 13, 2023 AND JUNE 26, 2023. THESE WERE OPPORTUNITIES FOR PET MANUFACTURERS (MEMBERS AND NON-MEMBERS) TO LEARN MORE ABOUT THE COALITION'S EFFORTS AND PROVIDE INPUT. AFTER GAINING CONSTITUENTS' INPUT, THE COALITION SUBMITTED FORMAL COMMENTS TO THE FDA DRAFT GUIDANCE TO EXPAND REMOTE REGULATORY ASSESSMENTS. COALITION CREATED FOUR WORKING GROUPS TO ADDRESS VARIOUS CONSTITUENT-RELATED NEEDS. COALITION DEVOTED MOST OF ITS ATTENTION TO CO-ORGANIZING WITH THE FDA THE 2023 PET DRUGS WORKSHOP (HELD NOVEMBER 13-14, 2023 AT THE FDA CAMPUS IN SILVER SPRING, VA), WHICH HAD THE HIGHEST LEVEL OF ATTENDANCE TO DATE, CONFIRMING THE IMPORTANCE OF PERIODICALLY ASSESSING THE STATE OF PET DRUG MANUFACTURING TO ENSURE CONTINUED PATIENT ACCESS TO LIFE SAVING IMAGING EXAMS. IT PROVIDED A FORUM FOR STAKEHOLDERS TO DISCUSS REGULATORY CONSIDERATIONS ON A WIDE RANGE OF TOPICS, INCLUDING FACILITY INSPECTIONS AND COMPLIANCE, PRODUCT QUALITY CONSIDERATIONS AND REGULATORY APPLICATIONS, CONTROL AND SAFETY ISSUES AND RISK MANAGEMENT AS WELL AS BROADER TRENDS IMPACTING PET DRUG REGULATION. COALITION CONTINUED TO DEVELOP ITS WEBSITE AS A RESOURCE FOR MEMBERS AND NON-MEMBERS.</DescriptionProgramSrvcAccomTxt>
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        <PersonNm>CHRISTOPHER C IGNACE</PersonNm>
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        <PersonNm>STEVEN R MATTMULLER</PersonNm>
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        <PersonNm>PETER SCOTT</PersonNm>
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