PRÓXIMAS FORMAÇÕES
Últimas Notícias
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
This integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the pre-submission guidance for access to the hyperlinked information. Questions and answers are being updated continuously and...
Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Readyto-Use Containers — “Dose Banding”
Having multiple different strengths of a drug product available in ready-to-use containers from which the entire drug content of the container(s) is administered to the patient may simplify the preparation and administration of a drug compared to preparing and...
Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence
FDA has interpreted this substantial evidence requirement as generally requiring two adequate 44 and well-controlled clinical investigations, each convincing on its own, to establish effectiveness. Nevertheless, as noted in the 1998 Effectiveness guidance, FDA has...
