May 25, 2022 Regulatory Sciences

How Important is Biostatistics?

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May 25, 2022 Agency Alerts

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 Agency Alerts

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 23, 2022 Clinical Research Solutions

Why Partner with a CRO that has In-House DCT Capabilities?

When you need to outsource your clinical trials and decentralized visits, it…

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May 20, 2022 Agency Alerts

FDA Draft Guidance: Risk Management Plans to Mitigate the Potential...

Industry Draft Guidance Drug shortages pose a significant public health threat as…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

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 Agency Alerts

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 Agency Alerts

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 Sciences

FDA Releases Draft Guidance for Industry on Clinical Pharmacology Considerations...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