U.S. Food & Drug Administration and European Medicines Agency approve first trastuzumab biosimilars U.S. Food & Drug...
Aydin Harston
To learn about Mr. Harston's practice, please visit http://www.rfem.com/professionals/hartsona.
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Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
By Aydin Harston and Andrew Storaska
European Medicines Agency newly approves two adalimumab biosimilars U.S. Food & Drug Administration approves first bevacizumab...
Tagged with: BPCIA, EMA, FDA, Regulatory
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Posted in:
Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
By Andrew Storaska and Aydin Harston
European Medicines Agency newly approves five rituximab biosimilars and an etanercept biosimilar, while recommending approval of...
Tagged with: BPCIA, EMA, FDA, Regulatory
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The U.S. Senate passed S.934 – FDA Reauthorization Act of 2017 on Thursday, August 3, 2017, by a 94-1 vote after having been passed by...
Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory
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By Aydin Harston and Andrew Storaska
H.R.2430 – FDA Reauthorization Act of 2017, a bill reauthorizing all of the U.S. Food and Drug Administration (“FDA”) user fee...
Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory
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The Biosimilar User Fee Act (“BsUFA”) was originally enacted in 2012, and the current legislative authority is set to expire at the end...
Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory