Remove tag validation
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Michigan State University’s Axia Institute Announces the Launch of Axia Lab™ as its RFID Tag Validation Program

BioTech 365

Michigan State University’s Axia Institute Announces the Launch of Axia Lab™ as its RFID Tag Validation Program Michigan State University’s Axia Institute Announces the Launch of Axia Lab™ as its RFID Tag Validation Program Global pharmaceutical leader Fresenius Kabi is … Continue reading →

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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

When a submission is sent through the FDA’s Electronic Submissions Gateway (ESG), it goes through an automated check of many validation rules, as specified in the Electronic Common Technical Document (eCTD) submission standards guidance. There are four HIGH-severity TRC validation codes for study data (Table 1): Table 1. Code 1734.

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Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

pharmaphorum

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. The $56,000-a-year price tag for the drug, which has now been cut in half in the US, also hasn’t helped the drugmakers make a case for Aduhelm with US payers.

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Sponsored content: Why choose Bethyl antibodies for your R&D

Drug Discovery World

We are vertically-integrated from immunisation through manufacturing and validation. All of our antibodies are highly validated using six pillars of validation, meaning that our antibodies do what we say they’ll do. Antibody validation. A proposal for validation of antibodies. Pillar 5: Protein OE/Epitope Tags.

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Can gene therapies for haemophilia defend their high price tags?

Pharmaceutical Technology

million price tag. While experts interviewed by Pharmaceutical Technology found the cost-effectiveness estimates valid, the durability of gene therapies in haemophilia remains unclear, particularly in the case of Roctavian, which has faced similar queries from regulatory authorities. million ($1.8 million at the time).

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Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH)

Rethinking Clinical Trials

Can we use measures that have been used previously for those populations and if we can how do we tweak them to make sure they are valid within this population? People with experience to prior disease that might be similar is where we started. Prior information, data and experience and then adapt it for patients with PASC.

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Grand Rounds January 26, 2024: Advancing the Safe, Effective and Equitable Use of AI in Healthcare (Mark Sendak, MD, MPP; Suresh Balu, MD, MBA)

Rethinking Clinical Trials

The discussion resulted in five assessment domains to be evaluated across the span of the AI adoption process: accountability, fairness, fitness for purpose, reliability and validity, and transparency. – How do you get reliable information and data for care that is received outside of Duke?