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Agency Alerts

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FDA Draft Guidance: Risk Management Plans to Mitigate the Potential...

Industry Draft Guidance Drug shortages pose a significant public health threat as…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 16, 2022 Agency Alerts

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production – Level...

Guidance for Industry May 2022 Today, FDA is announcing revisions to the…

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May 10, 2022 Agency Alerts

Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies

On May 5, 2022, the FDA announced the availability of a draft…

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