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JUMP DIRECTLY TO SLIDE Warning! Warning! Warning! Letters Public Learning Tools Presentation Outline FDA Warning Letters Read the SMALL PRINT of the 1572 (a) Read the SMALL PRINT of the 1572 (b) Read the SMALL PRINT of the 1572 (a) Read the SMALL PRINT of the 1572 (b) Read the SMALL PRINT of the 1572 (c) Read the SMALL PRINT of the 1572 (d) Read the SMALL PRINT of the 1572 (e) Read the SMALL PRINT of the 1572 (f) Read the SMALL PRINT of the 1572 (g) Read the SMALL PRINT of the 1572 (h) Read the SMALL PRINT of the 1572 (i) Read the SMALL PRINT of the 1572 (j) FDA Inspector Cometh Process (a) FDA Inspector Cometh Process (b) Step 10. FDA classifies Inspection (a) Step 10. FDA classifies Inspection (b) Audience Question FDA Warning Letters (WL) Warning Letter Case: 1572 WL (17 Apr 02): Yu, MD, PhD FDA Warning Letters (WL) Audience Question 1572 Commitments: Box 9 (a) 1572 Commitments: Box 9 (b) WL (27 Sep 02): Bear, MD, PhD WL (27 Sep 02): Bear, MD, PhD WL (27 Sep 02): Bear, MD, PhD Good Clinical Practice (GCP) (a) Good Clinical Practice (GCP) (b) Good Clinical Practice (GCP) (c) Warning Letter Cases: SMALL PRINT Issues Academic Investigator Cases What are the 1572 issues in each case? Review Warning Letters Audience Interaction Mitchell Creinin: Pittsburgh [Device] Audience Interaction Michael Gruber: NYU [Biologics] Audience Interaction Alkis Togias: John Hopkins [Drug] Audience Interaction Alkis Togias: John Hopkins [Drug] FDA Restricted List More info: Dr Togias: John Hopkins More info: Dr Togias: John Hopkins Read OHRP Determination Letters OHRP Determination Letters Audience Comment Audience Interaction Office for Human Research Protections (OHRP) Relationship of OHRP to UM OHRP looks at the Institution OHRP Compliance Procedures Contents of a letter from OHRP initiating a compliance action After Receiving a University Response OHRP compliance close-out letters Review Determination Letter: Case 1: John Hopkins University Audience Interaction Case 1: JHU (Dr. Rolley E. Johnson) Review Determination Letter: Case 2: Thomas Jefferson University Audience Interaction Case 2: TJU and Willis Eye Hospital Review Determination Letter: Case 3: Massachusetts General Hospital Audience Interaction Case 3: Mass General Hospital Review Determination Letter: Case 4: JHU (Lead paint abatement) Audience Interaction Case 4: JHU (Lead paint abatement) Reminder: Dr Togias: John Hopkins Summary 1 Summary 2        synchronize audio with current slide