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Compliance
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
Compliance
Top 7 pharma manufacturing regulatory stories of 2025
Dec. 29, 2025
Compliance
Trump inks drug pricing, tariff deals with nine biopharma companies
Dec. 22, 2025
Compliance
FDA slaps Novo Nordisk with warning letter over former Catalent site in Indiana
Dec. 18, 2025
cGMPs
Sun Pharma invests in new manufacturing facility in India amid FDA scrutiny
Dec. 3, 2025
Compliance
UK pharmaceuticals exempt from tariffs in US drug pricing agreement
Dec. 2, 2025
Compliance
Congress introduces bill to create national biomanufacturing center of excellence
Nov. 25, 2025
Compliance
Trump trade deal with Switzerland, Liechtenstein caps pharma tariffs at 15%
Nov. 17, 2025
Compliance
Thermo Fisher CEO says Most Favored Nation and tariff policies are better than feared
Oct. 22, 2025
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