Resources

Regulatory Documents 

 

FDA Guidance, Compliance and Regulatory Information 

https://www.fda.gov/drugs/guidance-compliance-regulatory-information

 

ICH Guidance Documents 

https://www.ich.org/

 

FDA Home 

https://www.fda.gov/

 

The United States Pharmacopeia-National Formulary

https://www.uspnf.com/

 

The Parenteral Drug Association 

https://www.pda.org/

 

International Society for Pharmaceutical Engineering 

https://ispe.org/

 

European Medicines Agency.

https://www.ema.europa.eu/en

 

Japan Ministry of Health, Labour and Welfare

https://www.mhlw.go.jp/english/

 

Pharmaceuticals and Medical Devices Agency PMDA

 https://www.pmda.go.jp/english/

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