FDA Law Blog: Biosimilars

JULY 7, 2024

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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Compliance Laboratories FDA Regulations 64

Drug Patent Watch

JULY 7, 2024

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.

Drugs 59

Drugs Marketing 59

Perficient: Drug Development

JULY 7, 2024

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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Drug Patent Watch

JULY 7, 2024

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.

Pharmaceuticals 59

Pharmaceuticals Drugs 59

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