Drugs

‘Uneven Readiness’ Seen for Supply Chain Law

The latest HDA Research Foundation “Serialization Readiness Survey” says there continues to be uneven readiness as supply chain partners prepare for the 2023 Drug Supply Chain Security Act (DSCSA) implementation milestone. “FDA’s granting of enforcement discretion in 2020 until 2023 for certain wholesale distributor and dispenser requirements, while very beneficial for the industry, has resulted in a perception among some trading partners that they can defer necessary 2023 investments and onboarding to the deadline,” the survey says.

HDA reports that 2% of manufacturers are still unsure when they plan to exchange data with wholesale distributors. “While this number is down from 16% last year,” it says, “it is concerning. An additional 32% of manufacturers are currently sending serialized data to their wholesale distributor customers upon shipment and 66% plan to do so by 11/2023.”

The consultants say the top reported concerns regarding overall implementation were the governance of the interoperable system, collaboration with trading partners, and technical challenges. “Moreover,” it says, “dispenser knowledge of DSCSA requirements continues to be an additional highlighted concern for distributors. The perceived knowledge across industry segments continues to be low, especially among independent pharmacies. As the open-ended comments indicated, educating dispensers with accurate information is critical and will continue to present issues going forward.”

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