570 556 captures · dernière capture : 3 mai 2026
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386 223 captures · dernière capture : 14 avr. 2026
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Draft Guidance for Industry, Preparation of the Quality Information for Radiopharmaceuticals (Schedule C Drugs) using the Quality Information Summary-Radiopharmaceuticals (QIS-R) and Certified Product Information Document Contact: CERB/CBE This document is also available in PDF…
Guidance Document - Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals for Use in Basic Clinical Research Studies (PDF Version - 263 K) Foreword Guidance documents are meant to provide assistance to industry and health care…
General Questions and Answers on Plant Molecular Farming (PMF) (PDF Version - 65 K) What is Plant Molecular Farming (PMF)? Why would drugs be grown in plants? How are drugs grown in plants? What are plant-derived biologic drugs? Are plant-derived biologic drugs as safe as other…
Guidance Document - Plant Molecular Farming (PMF) Applications: Plant-Derived Biologic Drugs for Human Use Date adopted: 2014-05-08 Effective date: 2014-05-08 (PDF Version - 638 K) Foreword Guidance documents are meant to provide assistance to industry and health care…
Policy Statement: Clarifying the appropriate regulatory pathway for subsequent entry low molecular weight heparins Draft Date: 2013/08/16 1.0 Purpose Health Canada's Biologics and Genetic Therapies Directorate ( BGTD ) is the Canadian federal authority that regulates biological…
Guidance Document: Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex Differences Date 05/29/2013 Foreword Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and…
Guidance document: Annual update of seasonal influenza vaccines (PDF Version - 433 K) Published by authority of the Minister of Health Date Adopted: 2015-01-12 Effective Date: 2015-01-30 Revised Date: 2016-03-17 Administrative updates: 2024-06-04 Foreword Guidance documents are…
Guidance document: Fecal microbiota therapy used in the treatment of Clostridioides difficile infection not responsive to conventional therapies (PDF Version - 316 K) Published by authority of the Minister of Health Date adopted: 2015-03-27 Effective date: 2015-03-27 Revised…
Guide d'administration des demandes des Instituts de recherche en santé du Canada (IRSC) Résumé des modifications (date en vigueur le 15 novembre 2019) Lignes directrices des IRSC sur la détermination de l'admissibilité des candidats principaux désignés à une subvention Lignes…
Guidance Document - Submission and Information Requirements for Extraordinary Use New Drugs (EUNDs) On this page Overview Applicable regulations Clinical trial applications Submission information and requirements Post-market requirements Labelling Changes following…
Version préliminaire : la couverture et les fonctionnalités sont encore en expansion.
