2012 PDA Regulatory Comments

Join/Renew |
Login

Login to Your PDA Account

Don't have an account yet? Create an Account Forgot your username or password? Recover account

Parenteral Drug Association Connecting People, Science and Regulation ^®

EMA Draft Guidance on Process Validation 30 Oct 2012

(?)
EU Commission Draft Guidance on GMP for Active Substances in Medicinal Products for Human Use 20 Apr 2012

(?)
FDA Draft Guidance on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product 13 Apr 2012

(?)
FDA Draft Guidance on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product 13 April 2012

(?)
FDA Draft Guidance on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product 13 Apr 2012

(?)