Tagged as: FDA

Comments and Letters to FDA in Response to Biosimilars Action Plan

The Association for Accessible Medicines (AAM) and Biosimilars Council submitted comments to FDA two weeks ago regarding “the biosimilars action plan and ways to facilitate competition” in the biosimilars industry. Collectively referred to in the comments as AAM, and the “sole association representing America’s generic pharmaceutical sector in the United States,”…

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FDA Releases Draft Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

Last week, FDA published its draft guidance on civil money penalties relating to the ClinicalTrials.gov data bank to the federal register.  The guidance addresses how the FDA Centers (CDER, CBER, and CDRH, for drug, biological, and device products, respectively) identify whether parties have failed to submit required clinical trial registrations, results,…

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Pfizer Submits Citizen Petition to FDA Regarding Communications About Biosimilars

On August 22, 2018, Pfizer submitted a citizen petition to the Food and Drug Administration requesting “guidance clarifying appropriate sponsor communications about the nature and properties of biosimilar products.”  Specifically, Pfizer petitioned FDA to clarify what constitutes a false and misleading communication with respect to the safety and effectiveness of biosimilars relative…

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IGBA Urges FDA to Waive the Requirement for Bridging Studies for Biosimilar Sponsors

In a letter to FDA last month, the International Generic and Biosimilar Medicines Association (IGBA), which represents member pharmaceutical companies from the USA, Canada, South Africa, India, Jordan, Japan, Europe and Taiwan, requested that FDA “revisit their position and waive the requirement of bridging studies.” Typically, biosimilar sponsors are required…

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FDA Releases Biosimilar Action Plan (BAP) to Enhance Biosimilar Competition and Market Penetration

Today, the U.S. FDA released its Biosimilar Action Plan (BAP), which outlines the Administration’s proposed next steps to help reduce the costs of healthcare by expediting the development of robust biosimilar competition and market penetration, while encouraging innovation and maintaining incentives for investing in future products.  In remarks delivered at…

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FDA Releases Guidance for Industry Regarding Implementation of Biosimilar User Fee Amendments of 2017

The FDA recently announced the availability of a final guidance for industry titled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.”   This guidance concerns the implementation of BsUFA II, which as we previously reported, extends FDA’s authority to collect user fees from fiscal year (FY) 2018 to…

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FDA Announces Early Communications Program

The FDA’s Center for Biologics Evaluation and Research (CBER) is launching a new program called INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs).  INTERACT meetings will replace pre-pre-IND meetings, but not formal product-specific meetings, such as pre-IND or pre-BLA meetings. According to the announcement, sponsors will be able to…

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