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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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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FDA Draft Guidance: Risk Management Plans to Mitigate the Potential...
Industry Draft Guidance Drug shortages pose a significant public health threat as…
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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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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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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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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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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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