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Regulatory Affairs Blog Posts

May 25, 2022 Regulatory Affairs

How Important is Biostatistics?

The link between statistical methods and healthcare is not a new one,…

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May 25, 2022 Regulatory Affairs

Importation of Prescription Drugs Final Rule Questions and Answers

Small Entity Compliance Guide on Final Rule on Importation of Prescription Drugs…

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May 24, 2022 Regulatory Affairs

EMA post-authorisation procedural advice for users of the centralised procedure

This guidance document addresses a number of questions which marketing authorisation holders…

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May 20, 2022 Regulatory Affairs

FDA Draft Guidance: Risk Management Plans to Mitigate the Potential...

Industry Draft Guidance Drug shortages pose a significant public health threat as…

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May 20, 2022 Regulatory Affairs

IRIS guide for applicants (How to create and submit scientific...

This guide has been produced to show applicants how to use the…

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May 19, 2022 Regulatory Affairs

EMA Regulatory and procedural guideline: Public consultation concerning the physical...

The COVID-19 pandemic required manufacturers and importers of medicinal products and regulatory…

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May 19, 2022 Regulatory Affairs

FDA Issues Final Guidance on Safety Considerations for Container Labels...

FDA has issued the final guidance titled “Safety Considerations for Container Labels…

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May 18, 2022 Regulatory Affairs

FDA Releases Draft Guidance for Industry on Clinical Pharmacology Considerations...

The FDA’s Office of Clinical Pharmacology within the Office of Translational Sciences…

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