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Regulatory Guidance

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Regulatory Guidance

FDA program to lower US onshoring barriers gets industry support

At the agency’s public meeting on the proposed PreCheck framework, companies said reductions in inspection-related delays could significantly de-risk and reduce timelines.
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
2021-FDA-approvals
Drug Approvals

FDA year in review: 50 novel drug approvals and more

Feb. 16, 2022

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