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Regulatory Guidance

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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
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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
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Regulatory Guidance

Anticipating AI regulations in pharma manufacturing

March 11, 2024
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2024 pharma predictions: Regulations, sustainability and culture

Jan. 31, 2024
Regulatory Guidance

Ocugen could face $10,000 FDA non-compliance fine

April 27, 2022
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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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