(UCSF) Dr. Jim Slater -Lecture: FDA Electronic Communications Process (FDA Registered Facility)

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Information about (UCSF) Dr. Jim Slater -Lecture: FDA Electronic Communications Process...

Published on February 16, 2018

Author: AnaMariaDeluca1

Source: slideshare.net

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7. Proprietary Name NDC Package Code Strength Dosage Form Route Appl. No. Labeler Name Product NDC Nonproprietary Name Substance Name Ammonia N 13 24275-0385-1 37.5 mCi/mL INJECTION INTRAVENOUS ANDA204496 UCSF Radiopharmaceutical Facility 24275-0385 NH3N13 AMMONIA N-13 Choline C 11 24275-0485-1 33.1 mCi/mL INJECTION INTRAVENOUS ANDA208444 UCSF Radiopharmaceutical Facility 24275-0485 Choline C-11 CHOLINE C-11 Fludeoxyglucose F18 24275-0185-1 300 mCi/mL INJECTION INTRAVENOUS ANDA203902 UCSF Radiopharmaceutical Facility 24275-0185 Fludeoxyglucose F18 FLUDEOXYGLUCOSE F-18 Sodium Fluoride 24275-0285-1 200 mCi/mL INJECTION INTRAVENOUS ANDA204437 UCSF Radiopharmaceutical Facility 24275-0285 SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18

8. Manufacture Labeler Code Lilly 0002 Squibb 0003 Merck 0006 GlaxoSmithK 0007 Bayer 0026 Pfizer 0069 GE Healthcare 0407 PET Manufacture Labeler Code Lantheus 11994 Feinstein 13267 UCSF 24275 PETnet 40028 Johns Hopkins 40089 Triad 60055 MD Anderson 60215

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13. Document Name Sender Recipient Date File Size Type ci1494359938210.6 69210@fdsuv08653 _te2.html FDA UCSF Radiopharmaceutical Facility May 9th 2017, 1:18:36 pm 1 KB Acknowledgement ci1494359938210.6 69210@fdsuv08653 _te2.txt FDA UCSF Radiopharmaceutical Facility May 9th 2017, 1:07:45 pm 197 bytes Acknowledgement Receipt for 2aa433eb-be1e- 42e0-96d1- df5e1d7ba51e.tar.g z.txt FDA UCSF Radiopharmaceutical Facility May 9th 2017, 12:58:59 pm 2 KB Receipt Status Document Name Center Type File Size Date Delivered 2aa433eb-be1e-42e0-96d1- df5e1d7ba51e.tar.gzReceipt2 Acknowledgements CDER GDUFA_Facility_Registration 3 KB May 9th 2017, 12:58:58 pm

14. Acknowledgement Total: Current Page of Loading Loading... File Name: ci1494359938210.669210@fdsuv08653_te2.txt Status: Delivered Date: May 9th 2017, 1:07:45 pm File Size: 197 bytes Submission Message Id: <32787849.01494359936537.JavaMail.JSlater@CB-CYCLOTRON-5> Sender: FDA Recipient: UCSF Radiopharmaceutical Facility Receipt Total: Current Page of Sent Details Loading Loading... File Name: 2aa433eb-be1e-42e0-96d1-df5e1d7ba51e.tar.gz Status: Delivered Date: May 9th 2017, 12:58:58 pm File Size: 3 KB Center: CDER Submission Type: GDUFA_Facility_Registration Submission Message Id: <32787849.01494359936537.JavaMail.JSlater@CB-CYCLOTRON-5> Sender: UCSF Radiopharmaceutical Facility Recipient: FDA

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21. • • • • • • • AFTER CREATION OF SPL FILES FDA REQUESTED TO VALIDATE YOUR SPL DOCUMENT BEFORE SENDING TO THE FDA USING THE PRAGMATIC VALIDATOR. • AFTER VALIDATING THE SUBMISSION SPL DOCUMENT ONLY THROUGH THE ESG TO FDA.

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