Drugs

2 Draft DSCSA Guidances Out

FDA has published two draft guidances covering portions of the Drug Supply Chain Security Act (DSCSA). The first guidance, DSCSA Standard for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs, identifies the standards necessary to facilitate the adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain. The document also clarifies the trading partners, products, and transactions subject to such standards.

The guidance revises an 11/2014 draft to update the policy articulated in that draft to reflect enhanced drug distribution security requirements that take effect 11/27/23.

The second guidance, Identifying Trading Partners Under the Drug Supply Chain Security Act, is to assist industry and state and local governments in understanding how to categorize the entities in the drug supply chain under the act. The document revises an 8/2017 guidance to address the status of some entities as trading partners, provide clarification on certain drug distribution scenarios, and address the interpretation of a section of the law that discusses third-party logistics providers’ licensure status before the effective date of forthcoming regulations establishing licensure standards.

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