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Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines

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Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions on the content of the draft document contact (CDER) Min Chen, 301-827- 3169 (phone); 301-827-5190 (fax), or (CBER) Miles Braun, 301-827-3974 (phone); 301- 827-3529 (fax). U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) March 2001 G:\4177dft.doc Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines Additional copies are available from: Drug Information Branch (HFD-210) Center for Drug Evaluation and Research (CDER) 5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4570 Internet at http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance (HFM-40) Center for Biologics Evaluation and Research (CBER) 1401 Rockville Pike, Rockville, MD 20852-1448 (Fax) 1-888-CBERFAX or 301-827-3844 (Voice Information) 1-800-835-4709 or 301-827-1800 Internet at http://www.fda.gov/cber/guidelines.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) March 2001 G:\4177dft.doc TABLE OF CONTENTS I. INTRODUCTION..................................................................................................................................................................1 A. WHAT DOES THIS GUIDANCE DISCUSS?.......................................................................................................................... 1 B. WHAT DOES THIS GUIDANCE NOT DISCUSS?................................................................................................................. 2 C. GOOD GUIDANCE PRACTICES............................................................................................................................................. 2 II. BACKGROUND....................................................................................................................................................................3 A. FINAL RULES....................................................................................................................................................................... 3 B. GUIDANCES ......................................................................................................................................................................... 3 C. PROPOSED RULES ............................................................................................................................................................... 4 III. WHO MUST REPORT.........................................................................................................................................................4 IV. WHAT DO I REPORT?.......................................................................................................................................................5 A. TYPE OF ADVERSE EXPERIENCES ..................................................................................................................................... 6 B. DATA ELEMENTS TO INCLUDE IN A POSTMARKETING INDIVIDUAL CASE SAFETY REPORT ......................................... 8 V. TYPE OF REPORTS ............................................................................................................................................................9 A. 15-DAY REPORTS OF SERIOUS, UNEXPECTED ADVERSE EXPERIENCES........................................................................ 9 B. PERIODIC REPORTS .......................................................................................................................................................... 11 C. FOLLOWUP REPORTS ....................................................................................................................................................... 15 D. DISTRIBUTION REPORTS FOR BIOLOGICAL PRODUCTS INCLUDING VACCINES ............................................................ 18 VI. SPECIAL REPORTING SITUATIONS .....................................................................................................................18 A. SCIENTIFIC LITERATURE REPORTS................................................................................................................................. 18 B. POSTMARKETING, CLINICAL TRIAL, OR SURVEILLANCE STUDIES ................................................................................ 19 C. FOREIGN REPORTS ........................................................................................................................................................... 20 D. DEATH REPORTS.............................................................................................................................................................. 20 E. OVERDOSE REPORTS........................................................................................................................................................ 20 F. LACK OF EFFECT REPORTS ............................................................................................................................................. 21 G. INFORMATION ON THE INTERNET.................................................................................................................................... 21 H. PEDIATRIC PATIENTS....................................................................................................................................................... 21 I. PRESCRIPTION DRUGS MARKETED FOR HUMAN USE WITHOUT AN APPROVED APPLICATION................................ 22 J. ANOTHER APPLICANT=S PRODUCT................................................................................................................................. 22 K. MULTIPLE SUSPECT PRODUCTS ..................................................................................................................................... 22 L. SUSPECT DRUGS WITH MULTIPLE NDAS OR ANDAS BY THE SAME APPLICANT ................................................... 23 M. TWO OR MORE MARKETERS OF A PRODUCT ................................................................................................................ 23 N. UNAPPROVED INDICATIONS ............................................................................................................................................. 23 O. PRODUCT INTERACTIONS ................................................................................................................................................ 23 P. REPORTS FROM THE FDA ............................................................................................................................................... 23 Q. PRODUCT DEFECTS.......................................................................................................................................................... 24 R. REPORTING AMBIGUITIES................................................................................................................................................ 24 VII. CODING OF ADVERSE EXPERIENCES IN INDIVIDUAL CASE SAFETY REPORTS ..................................24 VIII. REPORTING FORMATS.............................................................................................................................................25 A. FDA FORM 3500A........................................................................................................................................................... 25 B. VAERS FORM FOR VACCINES......................................................................................................................................... 28 C. CIOMS I FORM FOR FOREIGN ADVERSE EXPERIENCES................................................................................................ 29 D. DISTRIBUTION REPORTS FOR BIOLOGICAL PRODUCTS INCLUDING VACCINES ............................................................ 29 G:\4177DFT.DOC E. ELECTRONIC SUBMISSIONS.............................................................................................................................................. 30 IX. HOW AND WHERE TO SUBMIT POSTMARKETING SAFETY REPORTS.........................................................30 A. HUMAN DRUG PRODUCTS ............................................................................................................................................... 30 B. HUMAN BIOLOGICAL PRODUCTS AND VACCINES ........................................................................................................... 31 X. WRITTEN PROCEDURES FOR POSTMARKETING SAFETY REPORTING.......................................................31 XI. REQUESTS FOR WAIVERS TO POSTMARKETING SAFETY REPORTING REQUIREMENTS ....................32 A. SUBMISSION OF FDA FORM 3500A FOR NONSERIOUS,
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