FDA Policy/General

Latest Federal Register Notices

Q & A Guide on Biosimilar Development
9/17/2021 Federal Register notice: FDA has made available a final guidance entitled Questions and Answers on Biosimilar Development and the BPCI Act. The document is intended to inform prospective applicants about the development of proposed biosimilars and proposed interchangeable biosimilars. It also describes FDA’s interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009. The guidance revises a 2018 document under the same title. To view the notice, click here.

Revised Guide on Ferric Oxyhydroxide ANDAs
9/16/2021 Federal Register notice: FDA has made available a revised draft guidance for industry entitled Draft Guidance for Ferric Oxyhydroxide. The document provides product-specific recommendations on the design of bioequivalence studies to support ANDAs for ferric oxyhydroxide oral tablets and intravenous injectable products. To view the notice, click here.

Info Collection on Biosimilar User Fees
9/16/2021 Federal Register notice: FDA is seeking comments on an information collection revision entitled “Biosimilars User Fee Program” (OMB Control Number 0910-0718). For efficiency purposes, the agency is consolidating a related information collection on current user fee commitment goals as set forth in the document “BsUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022.” To view the notice, click here.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome