_dta: 1. by Jean Roth , jroth@nber.org , 3 Feb 2017 2. Source Page: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm070777.htm 3. Source File URL: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/UCM070783.zip 4. Source File: pmc_commitments.xlsx 5. You can differentiate postmarketing requirements (PMR) from postmarketing commitments (PMC) in 6. the far right column (Subpart Flag) of the download file. PMCs have no flag (field will be either Y or 7. Blank), PMRs have a code/flag to indicate which statutory authority they are required under. 8. cmt_desc has been truncated to 244 characters for pre-Stata13 9. cmt_status_desc has been truncated to 244 characters for pre-Stata13 cmt_id: 1. Internal identifier cmt_number: 1. PMR/PMC Number 2. Postmarketing Requirements (PMR) 3. Postmarketing Commitments (PMC) cmt_doc_type: 1. Application type cmt_doc_typestr: 1. Application type cmt_doc_type_no: 1. Set number (NDAs) or Supplement number for BLAs (0= original BLA) cmt_desc: 1. PMR/PMC Description cmt_status: 1. Pending: The study has not been initiated (i.e., no subjects have been enrolled 2. or animals dosed), but does not meet the criterion for delayed (i.e., the original 3. projected date for initiation of patient accrual or initiation of animal dosing has not passed). 4. Ongoing: The study is proceeding according to, or is ahead of, the original schedule. 5. The FDA considers a study to be ongoing until a final study report is submitted to the FDA, 6. as long as the activities are proceeding according to the original study schedule. 7. If patient accrual or animal dosing has started but is not complete, and the projected 8. date for completion of that milestone has passed, the study should be categorized as delayed. 9. Delayed: The progression of the study is behind the original study schedule. 10. Delays can occur in any phase of the study, including patient enrollment, analysis of study results, 11. or submission of the final study report to the FDA. While the original study schedule 12. - not a revised schedule - serves as the basis for defining a study as delayed, 13. each phase of the study will be considered in its own right. 14. If the applicant has one delayed phase, but gets back on schedule during the next phase, the delayed status will no longer apply. 15. Terminated: The applicant ended the study before completion, and has not yet submitted a final study report to the FDA. 16. Submitted: The applicant has concluded or terminated the study and has submitted 17. a final study report to the FDA, but FDA has not yet notified the applicant 18. in writing that the study commitment has been fulfilled or that the commitment has been released. 19. Fulfilled: The applicant has submitted the final study report for the commitment, 20. and upon review of the final study report, FDA is satisfied that the applicant has met the terms of the commitment. 21. Released: FDA has informed the applicant that it has been released from its 22. obligation to conduct the postmarketing study because the study is either no longer feasible or would no longer provide useful information. 23. Note: The "fulfilled" and "released" commitments will be displayed on the 24. Web site for not more than one year from the date the commitments are fulfilled or released. cmt_status_desc: 1. Explanation of Status annual_rpt_due_date: 1. Date PMR/PMC annual report due annual_rpt_recv_datetime: 1. Date last PMR/PMC annual report received nda_bla_approval_datetime: 1. Application Approval Date orig_proj_compl_datetime: 1. Original Final Report Due Date" nda_number: 1. New Drug Application (NDA) or Biologic License Application (BLA)number applicant: 1. Applicant Name product: 1. Product Name public_flag: 1. Is the PMR/PMC publicly reportable Y = Yes cder_or_cber: 1. CBER is Center for Biologics Evaluation & Research 2. CDER is Center for Drug Evaluation and Research 3. FDA Center CB = CBER or CD = CDER subpart_flag: 1. Regulation a PMR is required under. 2. Not applicable for PMCs subpart_flagstr: 1. Regulation a PMR is required under. 2. Not applicable for PMCs obs: 2,607 vars: 25 3 Feb 2017 13:42 size: 2,093,421 (_dta has notes) -------------------------------------------------------------------------------------------------------------------------------------------------------------- storage display value variable name type format label variable label -------------------------------------------------------------------------------------------------------------------------------------------------------------- cmt_id long %10.0g * Commitment ID cmt_number byte %10.0g * Commitment Number cmt_doc_type byte %44.0g cmt_doc_type * Commitment Document Type cmt_doc_typestr str1 %9s * Commitment Document Type cmt_doc_type_no str4 %9s * Commitment Document Type Number cmt_desc str244 %244s * Commitment Description cmt_status_str str1 %9s Commitment Status cmt_status float %10.0g cmt_status * Commitment Status cmt_status_desc str244 %244s * Commitment Status Description study_type byte %10.0g Study Type study_start_date byte %10.0g Study Start Date protocol_submission_date byte %10.0g Protocol Submission Date final_rpt_recv_date byte %10.0g Final Report Received Date annual_rpt_due_date byte %10.0g * Annual Repport Due Date annual_rpt_recv_datetime int %td * Annual Report Received Date nda_bla_approval_datetime int %td * New Drug Application (NDA) Biologic License Application (BLA) Approval Date orig_proj_compl_datetime int %td * Original Project Completion Date current_proj_compl_date byte %10.0g Current Project Completion Date nda_number long %10.0g * New Drug Application (NDA) Number applicant str74 %74s * Applicant product str204 %204s * Product public_flag str1 %9s * Public Flag cder_or_cber str2 %9s * Center for Biologics Evaluation & Research (CBER) or Center for Drug Evaluation subpart_flag byte %63.0g subpart_flag * Subpart Flag subpart_flagstr str1 %9s * Subpart Flag * indicated variables have notes -------------------------------------------------------------------------------------------------------------------------------------------------------------- Sorted by: cmt_id cmt_doc_type: 2 Original Biologics License Application (BNA) 14 Original New Drug Application (NDA) 15 Other 19 Supplemental NDA or BLA cmt_status: 1 Ongoing 2 Pending 3 Delayed 4 Terminated 5 Submitted 6 Fulfilled 7 Released subpart_flag: 1 Accelerated Approval 4 Deferred pediatric under Pediatric Research Equality Act (PREA) 6 Food and Drug Administration Amendments Act (FDAAA) 8 Accelerated Approval 14 Animal Efficacy Rule 16 Deferred pediatric under Pediatric Research Equality Act (PREA) 25 PMCs