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EMEA: Draft EudraVigilance access policy for medicines for Veterinary use

30.01.2009
EMEA:
Draft EudraVigilance access policy for medicines for Veterinary use. This document should serve as a starting point for the elaboration of EudraVigilance access policies and the ...

FDA: Guidance for Industry - Labeling OTC Human Drug Products – Questions and Answers

30.01.2009
FDA:
Guidance for industry - Labeling OTC Human Drug Products – Questions and Answers. This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter ...

FDA: Comprehensive List of Guidance Documents

30.01.2009
FDA:
Center For Drug Evaluation and Research - Comprehensive List of Guidance Documents ...

FDA: Guidance for Industry - Annex 2 Test for Extractable Volume of Parenteral Preparations General Chapter

30.01.2009
FDA:
Guidance for Industry - Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. Annex 2 Test for Extractable Volume of Parenteral Preparations General ...

FDA: Guidance for Industry - Annex 3 Test for Particulate Contamination: Subvisible Particles General Chapter

30.01.2009
FDA:
Guidance for Industry - Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. Annex 3 Test for Particulate Contamination: Subvisible Particles General ...

FDA: Guidance for Industry - Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages (draft)

30.01.2009
FDA:
Guidance for Industry - Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages (draft). In this guidance, FDA is ...

MHRA: Guidance on writing patient information leaflets

MHRA has developed specific guidance on writing patient information leaflets (PILs). ...

How CMDh helps Marketing Authorisation Holders (MAHs) to facilitate regulatory procedures during the COVID-19 crisis?

The SARS-CoV-2 virus pandemic has undoubtedly affected various areas of our lives, not only our private lives and interpersonal contacts, but it has also firmly affected the areas of lives ...

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