Drugs

Drug Tracing ‘Stabilization Period’

FDA has published two compliance policy guidances establishing a one-year stabilization period to accommodate the additional time that trading partners in the drug supply chain may need to adhere to Drug Supply Chain Security Act (DSCSA) requirements for electronic drug tracing at the package level. The requirements that were to take effect on 11/27 include requiring trading partners to provide, receive, and maintain documentation about products and ownership only electronically. FDA says the stabilization period will give until 11/27/2024 to allow trading partners to implement, troubleshoot, and mature their electronic interoperable systems.

FDA says it “expects trading partners to use this stabilization period to build and validate interoperable systems and processes, manage products and data, and ensure continuity of the supply chain and product availability to patients. This period is not intended to provide, and should not be viewed as providing, a justification for delaying efforts to comply with the DSCSA.”

The first compliance policy guidance, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act—Compliance Policies, takes effect immediately and describes the agency’s compliance policies on enforcement of the requirements for enhanced drug distribution security requirements.

A revised final compliance policy guidance, Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies, describes the agency’s compliance policies on enforcement of requirements for wholesale distributors and dispensers to verify a product’s product identifier in certain circumstances.

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