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FDA previously provided recommendations for postapproval manufacturing changes to biosimilars as part of a September 2021 final guidance. The agency did not include recommendations for postapproval manufacturing changes to interchangeable biosimilars at that time. The age...
Earlier this month, the United States Food and Drug Administration (FDA)issued new draft guidance on how it plans to expedite its review of biosimilar or interchangeable application supplements. Thedraft guidanceprovides recommendations to applicants seeking of a proposed biosimilar or proposed interchangea...
GUIDANCE DOCUMENT: Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act. Draft Guidance for Industry. FDA. 15. 09. 2023. 9 Things to Know About Biosimilars and Interchangeable Biosimi...
This update moved five questions from the draft guidance to the final guidance and updated seven other questions in the final guidance. Additionally, two questions in the draft guidance have been withdrawn. The final guidance represents the FDA’s current thinking on the issue and does not establi...
It is important to recognize that this is a guidance for industry, “not a statement that says ‘all biosimilars are interchangeable with reference products,”David T. Rubin, MD,professor of medicine at University of Chicago Medicine, toldHealioGas...
FDA Guides the Way to Biosimilars in the US.The article offers the author's insights on the implications of the draft guidance from the U.S. Food and Drug Administration (USFDA) for the healthcare industry on how to get biosimilar products. She says that the draft provides documents for ...
FDAreleasesthreebiosimilarsguidances The U.S. FDA finalized and published three new guidances which clarifies what’s needed to submit so-called 351(k) applications to the agency in order to gain new approvals. Although companies are eagerly awaiting the guidance on interchangeability and also clos...
entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” According to the FDA, the draft guidance is “intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well...
2、FDA Guidance Documents (可查询指南性文件,如指导原则、法规等)这里提供一个方便的方法,从一个入口搜索所有的FDA相关的指导文件,例如:重点查看CGMP和CMC相关的指南更新情况: 3、Recalls, Market Withdrawals, & Safety Alerts 可查询产品的召回、撤市和安全警报等情况;召回、撤市和安全警报在FDA网站上可使用三年...