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Regulatory Guidance
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
Regulatory Guidance
FDA program to lower US onshoring barriers gets industry support
Oct. 1, 2025
Regulatory Guidance
FDA launches PreCheck program to accelerate US drug manufacturing
Aug. 7, 2025
Regulatory Guidance
Anticipating AI regulations in pharma manufacturing
March 11, 2024
Home
2024 pharma predictions: Regulations, sustainability and culture
Jan. 31, 2024
Regulatory Guidance
Ocugen could face $10,000 FDA non-compliance fine
April 27, 2022
Regulatory Guidance
Supporting continued process verification
April 15, 2022
Regulatory Guidance
FDA shares gene therapy research guidance
March 17, 2022
Regulatory Guidance
FDA hits Zydus with trio of observations
March 11, 2022
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