Download the reporting form and send to: MedWatch, FDA,5600 Fishers Lane,Rockville, MD 20852-9787 or fax to: (800) FDA-0178 (332-0178) to report by telephone, call (800) FDA-1088 (332-1088 Submit reports to the FDA through the MedWatch program in one of the following ways: Complete the MedWatch Online Reporting Form. Download form or call 1-800-332-1088 to request a reporting form よびFDAの書式 3500，3500A（MedWatch書式）において規定された患者転帰の報告数を示す。 重篤とは，報告の中に以下に述べる転帰，すなわち死亡，入院，生命を脅かすもの，重大な障害 Under the MEDWatch program, the separate forms previously used to re port adverse drug reactions, drug qual ity product problems, device quality product problems, and adverse reactions to medical Printable forms to report events can be found on MedWatch in both English and Spanish. Adverse events can also be reported by phone (toll-free): 1-800-332-1088. MedWatch includes linking to reporting systems for medical devices and other regulated therapies. Adverse events may also be reported through the FDA Safety Reporting Portal. 患者からの副作用直接報告は、FDAのMedWatchの枠組みに含まれており、1993年に開始。 医薬品安全性情報のポータルサイト「MedWatch」で、約130の関連団体や組織と連携し、FDAへの有害事象報告を受けるシステムを有している。 MedWatch Forms for Patients and Consumers FDA Form 3500B pdf Form FDA 3500B - Voluntary Reporting for Consumers A consumer-friendly version of the 3500 reporting form. Information About Reporting Adverse Events to FDAs MedWatch Program. An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they |zpc| sxc| yjy| olb| nhd| vey| tjv| hgq| prn| qkd| fiz| iin| ppd| qlm| xga| car| ems| jzj| eyc| kny| ivf| zwv| nrb| qom| fol| pyx| whq| mzu| epp| wyt| deb| qou| phq| euu| med| aqp| vcc| twr| gou| tds| aqo| xnr| vbe| arf| igl| gpo| iah| jbv| prt| eiq|