Will Tenbarge

May 23, 2024 | lexology.com | Deborah Cho |David Fox |Jason Conaty |Komal Karnik Nigam |Will Tenbarge

The U.S. Food and Drug Administration (FDA) recently released a podcast on biosimilars, featuring Dr. Sarah Yim, director of FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB), that seems to indicate a potential move away from differentiating non-interchangeable biosimilars and interchangeable biosimilars.

Mar 11, 2024 | lexology.com | Heidi Forster Gertner |Bill Ferreira |Randy Prebula |Yetunde Fadahunsi |Will Tenbarge

As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) published new draft guidance on how to present key information at the beginning of an informed consent document.

Jan 29, 2024 | jdsupra.com | Lynn Mehler |Will Tenbarge

January 29, 2024 To embed, copy and paste the code into your website or blog: Enacted in December 2019 as part of the Further Consolidated Appropriations Act of 2020, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (21 USC 355-2) addresses concerns that some brand manufacturers improperly restricted access to their products.