FDA Policy/General

FDA Publishes 2 Revised VICH Guidances

FDA has published two revised guidances issued by the Veterinary International Conference on Harmonization dealing with the validation of analytical procedures in veterinary drug applications. The documents say the revisions replace those made available in 7/1999 and 10/2010 and update contact information, standard disclaimer language, and formatting.

The first guidance, Validation of Analytical Procedures: Definition and Terminology, discusses the characteristics for consideration during the validation of the analytical procedures included as part of a registration application submitted in the EU, Japan, and the U.S. The guidance says the objective of a validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose.

The second guidance, Validation of Analytical Procedures: Methodology, provides guidance and recommendations on how to consider the various validation characteristics for each analytical procedure included as part of a registration application for approval of veterinary medicines. The document says that other approaches may be applicable and acceptable and it is up to the applicant to choose the validation procedure and protocol most suitable for their product.

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