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Regulatory Guidance
Regulatory Guidance
FDA launches PreCheck program to accelerate US drug manufacturing
The agency’s new two-phase regulatory framework seeks to strengthen domestic supply chain and reduce foreign dependence on active pharmaceutical ingredients.
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
Drug Approvals
FDA year in review: 50 novel drug approvals and more
Feb. 16, 2022
Regulatory Guidance
The fallout from Aduhelm
Dec. 14, 2021
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