Drugs

New FDA Drug Supply Chain Guidances

FDA has finalized two guidances and published two draft guidances to help ensure that prescription drugs are identified and traced properly as they move through the supply chain. An agency online notice says the documents provide agency recommendations for how to comply with applicable Drug Supply Chain Security Act (DSCSA) requirements, including those for enhanced drug distribution security at the package level that take effect 11/2023.

Industry questions about the use of product identifiers on drug packages are answered in the finalized guidance Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers.

The final guidance Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification is to aid certain trading partners in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. It also describes how trading partners should notify FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with the agency.

A revised draft guidance, Definitions of Suspect Products and Illegitimate Product for Verification Obligation Under DSCSA, gives FDA’s current understanding of terms used to define “suspect” and “illegitimate” products. In response to stakeholder comments, it revised a 3/2018 draft guidance.

Finally, a new draft guidance, Enhanced Drug Distribution Security at the Package Level Under DSCSA, is to assist supply chain stakeholders, particularly trading partners, with requirements for enhanced drug distribution security at the package level that take effect 11/27/23. The guidance provides recommendations on the system attributes necessary for enabling the secure tracing of product at the package level.

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’

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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