Sun.Jul 07, 2024

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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog: Biosimilars

By Gail H. Javitt — In its final rule on laboratory developed tests (LDTs) (see our prior blog here ), FDA acknowledged that “some laboratories may lack familiarity, experience, or existing infrastructure for complying with FDA requirements” and made multiple references to a “small entity compliance guidance” that the agency intended to publish to “provide additional guidance to small businesses.

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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.

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AI Toolkits Magic: Automating CAPTCHA Recognition Using OpenCV and Tesseract

Perficient: Drug Development

OpenCV and Tesseract can be associated with Artificial Intelligence due to their involvement in tasks that often fall under the AI umbrella, such as computer vision and text recognition. To automate solving image CAPTCHAs using Java, you will typically need several dependencies for tasks such as image processing, machine learning, and possibly computer vision.

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Which pharmaceutical drugs have the most drug patents in France?

Drug Patent Watch

This chart shows the drugs with the most patents in France. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.