FullText A new, “easy-to-read” standardized document proposed by the US Food and Drug Administration (FDA) would help patients use their prescription drugs or biological products more safely and effectively, the agency said in astatement. The 1-pagePatient Medical Informationguide includes the ...
FDA将非处方药定义为安全性、有效性适合广大公众在无医生处方的情况下使用的药品。 Patient Package Insert(PPI) 患者药品包装说明书 患者药品包装说明书包含了让患者理解如何安全用药的信息。 Pharmaceutical Equivalents 药学等价 FDA认为满足以下条件的药品是药学等价的: 含有...
Drugs@FDA的药品的市场状态分为四类: 处方、非处方(OTC)、断续药品、暂定批准。 Medication Guide医疗指导 医疗指导包含患者如何安全使用该药品的信息。 New Drug Application(NDA)新药申请 当新药赞助者认为有足够的证据证明该药的安全性、有效性能满足FDA的批准上市的要求时,赞助者向FDA提交新药申请。申请必须在化学...
Drugs@FDA的药品的市场状态分为四类: 处方、非处方(OTC)、断续药品、暂定批准。 Medication Guide医疗指导 医疗指导包含患者如何安全使用该药品的信息。 New Drug Application(NDA)新药申请 当新药赞助者认为有足够的证据证明该药的安全性、有效性能满足FDA的批准上市的要求时,赞助者向FDA提交新药申请。申请必须在化学...
如果FDA确定需要执行REMS,则FDA可能会要求REMS包含一个或多个要素,其中包括药物指南(medication guide)、患者手册(patient package insert)、沟通计划(communication plan)、用药安全保障措施(elements to assure safeuse, ETASU)以及实施系统(implementation system)。
Food and Drug Administration's (FDA) directive regarding the attention-deficit/hyperactivity disorder (ADHD) medication. The FDA has directed manufacturers of drugs approved for the treatment of ADHD to develop patient medication guides to make consumers aware of possible health risks such as ...
infections and evaluated immediately if infection is suspected. Ultomiris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Ultomiris must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and ...
3 Contains Nonbinding Recommendations • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). • Advise the patient to read the FDA-approved patient labeling (Medication Guide). • Advise the patient to read the FDA-approved patient ...
Medication Guide医疗指导 医疗指导包含患者如何安全使用该药品的信息。New Drug Application(NDA)新药申请 ...
must be dispensed with a patient Medication Guide thatdescribes important information about the drug’s uses and risks. Patientsshould also be advised not to donate blood or blood products during treatment.Health care providers should also monitor patients for changes in theelectrical activity of the...