Search Results: test U.S. FDA News

FDA Webinar To Discuss the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S.

Next Tuesday (December 5) between 1:00-2:30pm (EST), FDA’s Division of Drug Information is presenting a webinar titled an “Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S.”  The webinar will provide an overview of the regulatory framework for biosimilar products, “including a background,…

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FDA Announces New Draft REMS Guidance

  Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all manufacturers of the same drug, which eliminates duplicative paperwork. This draft guidance is part of the FDA’s new…

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FDA Releases Biosimilars Educational Materials

On October 23, 2017, FDA announced the release of new educational materials to help health care professionals understand what biosimilars are and how they are approved.  The materials include four fact sheets and graphics that provide definitions for relevant terminology, describe the biosimilar approval process, and explain the benefits of biosimilars.  FDA also created social media posts for external…

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FDA Announces Biosimilar User Fee Act Rates for FY2018

Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2018 federal fiscal year, which runs from October 2017 through September 2018.  The FDA determined these rates pursuant to the Food and Drug Administration Reauthorization Act (FDARA), signed into law on August 18, 2017.  Among other things,…

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FDA Reauthorization Act of 2017 passes the House

Earlier this month, the House of Representatives passed H.R. 2430: FDA Reauthorization Act of 2017 (FDARA) by voice vote. The FDARA seeks, among other things, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar…

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CMS Considers New Billing Code Policy for Biosimilars

Last week, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule regarding payment policies.  Among other things, the proposed rule included a request for comment on the policy for biosimilar reimbursement.  A fact sheet prepared by CMS explains that the existing policy, finalized in 2016, provided that…

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