Biologics

Forms FDA 3988 and 3989 Guidance

FDA has published a guidance, Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989, to give information to applicants that are required to report annually on the status of postmarketing studies and clinical trials for human drug and biological products under Section 506B of the Federal Food, Drug, and Cosmetic Act (FFDCA) and its implementing regulations. The document describes the purpose and content of form FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and form FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics, including when to use the forms and how to submit them.

FDA says the guidance does not apply to postmarketing studies or clinical trials that are not subject to the reporting requirements of Section 506B of the FFDCA. Thus, it does not apply to voluntary studies or clinical trials conducted by an applicant or on an applicant’s behalf that are neither required nor agreed upon in writing. It also does not apply to chemistry, manufacturing, and controls commitments and stability studies that are not subject to Section 506B requirements.

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