Drugs

Biosimilar Postapproval Manufacturing Change Guide

FDA has posted a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products; Questions and Answers.” The document provides answers to common questions from applicants and other interested parties about postapproval manufacturing made to licensed biosimilars and interchangeable biosimilars. It is intended to inform applicants about the nature and type of information that they should provide to support such manufacturing changes in different reporting categories.

Under FDA’s regulations, applicants must tell the agency about each change in the product, production process, quality controls, equipment, facilities, or responsible personnel. Additionally, before distributing a product that has been changed, an applicant must assess the effects of the change and demonstrate through appropriate validation or other clinical/nonclinical laboratory studies the lack of unintended effects from the change on the identity, strength, quality, purity, or potency of the product as these factors may relate to the safety or effectiveness of the product. They must also inform FDA about each labeling change in the approved BLA.

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