JNM Global

Global Approval Partner

AdverseEvent 3

FDA, Reporting By Health Professionals

Voluntary Adverse Event Report Form FDA 3500 and FDA 3500B FDA建议对产品异常情况及具有严重副作用或使用错误等事件自觉进行异常报告。 * FDA 3500:Used by Health Care professional * FDA 3500B:Patents or Consumers for voluntary reporting * FDA 3500A:Mandatory Device Reporting Form (法律要求) 提交Voluantary Reporting,可以使用以下方法。 - 通过 Online提交Form MedWatch Online Voluntary Reporting Form Health professionals, consumers and patients can voluntar..

FDA, Reporting By Health Professionals

Voluntary Adverse Event Report Form FDA 3500 and FDA 3500B FDAは製品の異常及び副作用あるいは使用エラー等と同じ事件に対する 自発的な異常報告を勧奨しています。 *FDA 3500 : Used by Health Care professional *FDA 3500B : Patents or Consumers for voluntary reporting *FDA 3500A : Mandatory Device Reporting Form (法的要求事項) Voluntary Reporting提出の為には、下記と同じ方法を使用することができます。 -Onlineを通じたFormを提出 https://www.accessdata.fda.gov/scripts/medwatch/ -Telephoneを通した報..