Los biosimilares son como los genéricos en algunos aspectos, en el sentido de que ambos tipos de medicamentos se comparan con un producto de referencia (original) […]

En Español  Biosimilars: what patients need to know A biosimilar and its original biologic are made from the same types of sources – and have the […]

Docket Number: FDA-2019-D-3953 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Oncology Center of Excellence FDA is […]

Español 药物安全通讯 Drug Safety Podcasts The FDA Drug Safety Communications posted on this web page are intended to provide important information to patients and health care professionals about […]

Docket Number: FDA-2020-D-1079 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance outlines FDA’s current thinking on several topics relevant to clinical […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

Docket Number: FDA-2021-D-1051 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides recommendations to assist […]

Summary Company Announcement Date: March 28, 2024 FDA Publish Date: March 28, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety […]