Importation of Prescription Drugs Final Rule Questions and Answers
Small Entity Compliance Guide on Final Rule on Importation of Prescription Drugs…
Read Agency AlertEMA post-authorisation procedural advice for users of the centralised procedure
This guidance document addresses a number of questions which marketing authorisation holders…
Read Agency AlertFDA Draft Guidance: Risk Management Plans to Mitigate the Potential...
Industry Draft Guidance Drug shortages pose a significant public health threat as…
Read Agency AlertIRIS guide for applicants (How to create and submit scientific...
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Read Agency AlertEMA Regulatory and procedural guideline: Public consultation concerning the physical...
The COVID-19 pandemic required manufacturers and importers of medicinal products and regulatory…
Read Agency AlertFDA Issues Final Guidance on Safety Considerations for Container Labels...
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Read Agency AlertInvestigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production – Level...
Guidance for Industry May 2022 Today, FDA is announcing revisions to the…
Read Agency AlertClinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
On May 5, 2022, the FDA announced the availability of a draft…
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