Regulatory Guidance

FDA PreCheck pilot program accepts applications, looks to speed up US buildouts

The agency will select new pharma manufacturing facilities for the pilot aimed at reducing inspection-related delays and creating a more predictable regulatory pathway.

Feb. 2, 2026

Regulatory Guidance

FDA PreCheck pilot program accepts applications, looks to speed up US buildouts

FDA launches pilot to speed up review for US generic drug manufacturing, testing

FDA program to lower US onshoring barriers gets industry support

FDA launches PreCheck program to accelerate US drug manufacturing

Anticipating AI regulations in pharma manufacturing

2024 pharma predictions: Regulations, sustainability and culture

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

Supporting continued process verification

FDA shares gene therapy research guidance

Looking for Something?

Regulatory Guidance

FDA PreCheck pilot program accepts applications, looks to speed up US buildouts

FDA launches pilot to speed up review for US generic drug manufacturing, testing

FDA program to lower US onshoring barriers gets industry support

FDA launches PreCheck program to accelerate US drug manufacturing

Anticipating AI regulations in pharma manufacturing

2024 pharma predictions: Regulations, sustainability and culture

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

Supporting continued process verification

FDA shares gene therapy research guidance

Looking for Something?

FDA PreCheck pilot program accepts applications, looks to speed up US buildouts