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  • October 13, 2026
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Micron leads sixth-generation DRAM samples, but EUV strategy could determine future DRAM race

In late February, Micron announced it had shipped samples of its sixth-generation DRAM (1γ DRAM), becoming the first in the…

Manus vs. DeepSeek: disruptive AI breakthrough or just smoke and mirrors?

China’s latest AI sensation, Manus, is being marketed as the world’s first general-purpose AI agent. Overnight, it became a trending…

Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)

As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to…

Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to Mislabeling of Infusion Bag

Dr. Reddy’s Laboratories Ltd is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL…

Science & Research

In collaboration with industry and the public, FDA creates an annual list of regulatory science initiatives on generic drugs.

Generic Drug Development

News and Announcements updated

Abbreviated New Drug Application (ANDA) Forms and Submission Requirements

This page is a resource for ANDA Forms and Submission Requirements

Drug Shortages

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Jack Daniel’s maker says Canada pulling stock worse than tariffs

Brown-Forman’s CEO worries the response to U.S. duties by retailers could spread to Europe.