Drugs

BPCIA and Biosimilar Development Q&A

FDA has published a draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, with answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act (BPCIA) of 2009. The document says the question-and-answer format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable products, we well as describe the agency’s interpretation of certain statutory requirements added by the BPCIA.

“FDA believes that guidance for industry that provides answers to commonly asked questions regarding FDA’s interpretation of the BPCIA will enhance transparency and facilitate the development and approval of biosimilar and interchangeable products,” the guidance says. “In addition, these Q&As respond to questions the agency has received from applicants regarding the submission of biologics license applications for biosimilar and interchangeable products. FDA may provide additional Q&As through draft guidance as appropriate.”

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