Drugs

ICH Working on Generic Drug Standards Harmonization

The International Conference on Harmonization (ICH) has issued a “reflection paper” outlining a strategic approach for developing and enhancing ICH guidelines to support harmonization of scientific and technical standards for generic drugs. As part of the approach, the paper outlines recommendations to develop a series of ICH guidelines on standards for demonstrating equivalence for (1) non-complex dosage forms, and (2) more complex dosage forms and products. To accomplish the work, it recommended establishment of a generic drug discussion group to assist in assessing the feasibility of harmonization of standards for generic drugs and to prioritize work areas.

Moving the process forward, ICH has issued a description of an informal generic drug discussion group that will be a technical discussion group for issues relevant to harmonization of scientific and technical standards for generic drugs. The group is to recommend areas for harmonization and assess feasibility of harmonization of various topic areas within existing regional regulatory frameworks.

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