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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 ...

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 ...

MHRA: Guidance on writing patient information leaflets

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

Inevitable inspections ...

Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. It is essential to ...

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 ...

Safety management is key to any clinical trial and an utmost obligation to any pharmaceutical company introducing new medicinal products to the market. Whilst conducting a clinical trial, safety ...