Drugs

FDA Claims Transparency, Value for Complex Generic Drugs

CDER Office of Generic Drugs (OGD) Office of Research and Standards director Robert Lionberger says OGD has taken many steps to encourage the development of complex generic drugs (drugs that have complex active ingredients, dosage forms, routes of administration, or drug-device combinations). In an online post, Lionberger outlines the steps taken under the Generic Drug User Fee Amendments and also outside of that law.

He says FDA has approved more than 100 complex generic drugs each year since 2018 and each month new complex generic options become available to patients in need.

“Ensuring transparency and clarity during the assessment process, publishing guidance documents based on the latest science, and conducting and publishing scientific research help drive complex generic product approvals that meet our high scientific standards,” Lionberger writes. “We know the promise and potential of complex generics, and we intend to focus our regulatory and scientific initiatives to expand and strengthen this important area of our nation’s public health system.”

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