Drugs

PhRMA, BIO Petition FDA on Biosimilar Labeling

Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization have jointly filed a citizen petition urging FDA to take certain actions related to biosimilar product labeling. Specifically, they ask FDA to ensure that biosimilar labeling should:

1. State that the product has been approved as a biosimilar for the stated indications and routes of administration and identify the reference product;

2. Describe the basis of approval for each indication by identifying the relevant data for the reference product and biosimilar that support a biosimilarity finding; and

3. State whether or not the agency has made an interchangeability determination.

The groups say that the requested labeling approach will “facilitate informed prescribing, protect against inadvertent substitution, and promote consistency with domestic and international precedents.” Their petition also requests that FDA’s planned draft guidance on biosimilar labeling reflect these principles. Developing the biosimilar labeling policy through the public guidance process “will ensure that stakeholders receive notice and an opportunity to comment on FDA’s policies on this important topic before they are applied,” they say.

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