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Compliance
Regulatory Guidance
FDA launches pilot to speed up review for US generic drug manufacturing, testing
Designed for the review of abbreviated new drug applications, the program is meant to strengthen the domestic pharmaceutical supply chain in the United States.
Oct. 6, 2025
Compliance
Trump’s Oct. 1 pharma tariff is on hold amid pricing talks with drugmakers
Oct. 2, 2025
Compliance
Pfizer agrees to lower US drug prices, locks in three-year tariff grace period
Oct. 1, 2025
Regulatory Guidance
FDA program to lower US onshoring barriers gets industry support
Oct. 1, 2025
Compliance
Trump says some drugmakers face a 100% pharma tariff on October 1
Sept. 26, 2025
cGMPs
US onshoring is too slow, complex to drive near-term tailwind in bioprocessing
Sept. 23, 2025
Validation
ElevateBio earns ICMC certification for gene and cell therapy capabilities
Aug. 14, 2025
Regulatory Guidance
FDA launches PreCheck program to accelerate US drug manufacturing
Aug. 7, 2025
Sponsored
The 4 Key Compendial Measurements for Pharmaceutical Water Compliance
April 29, 2025
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