Drugs

Nanomaterial Drug, Biologic Product Guidance

FDA has published a guidance, Drug Products, Including Biological Products, that Contain Nanomaterials, providing guidance on the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The document says FDA does not categorically judge all products containing nanomaterials or otherwise involving the use of nanotechnology as intrinsically benign or harmful. “Rather,” it says, “for all products (nanotechnology-derived or otherwise), FDA considers the characteristics of the product and its safety and effectiveness for its use.”

FDA says the guidance finalizes a 12/18/17 draft, incorporating two noteworthy changes in response to stakeholder comments. First, the final guidance has a glossary of terminology to assist in understanding how important terms are used in it. Second, several revisions were made to reflect the agency’s current thinking on abbreviated applications, including ANDAs, for products containing nanomaterials.

The guidance contents are Introduction; Scope; Risk-Based Framework: Potential Risk Factors for Products Containing Nanomaterials; Nonclinical Studies for Drug Products; Clinical Development; Environmental Impact Considerations; and the Glossary.

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