Drugs

No Need Now for Insulin, Growth Hormone Product Guidance: FDA

FDA has denied an 8/3/06 petition from the governors of Kansas, Minnesota, Vermont, and Wisconsin asking that the agency issue product-specific guidance for the development of insulin and human growth hormone (HGH) that are therapeutically equivalent to branded products approved by FDA. The petition also asked that FDA commit to working with drug companies developing such products and to expediting the application process so that these products can be approved and made available to patients as quickly as possible. That portion of the petition request was approved “in that FDA remains committed to fostering the efficient development of biosimilar and interchangeable insulin and HGH products to expand access and improve the lives of patients and their families,” even though it no longer evaluates whether an insulin or HGH product is therapeutically equivalent to another insulin or HGH product.

In its 3/19 response, the agency notes that it “has been actively working for many years to facilitate efforts by manufacturers to develop and obtain approval of marketing applications for insulin and HGH products, and thereby encourage competition.” It says it has emphasized that the lack of a product-specific guidance does not limit its ability to work with prospective applicants of proposed insulin and HGH products on a product-specific basis.

Also, it says, since insulin and HGH products are now regulated under the Public Health Service Act as of 3/23/20, the agency no longer evaluates whether they are therapeutically equivalent to another product and thus the request to issue guidance is moot.

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