Health Canada Combination Products

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Drug/Medical Device Combination Products - Canada.ca

(3 days ago) The purpose of this policy is to ensure timely access to drug/medical device combination products by establishing a single window approach and more efficient submission processing system, while ensuring that … See more

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/drug-medical-device-combination-products.html

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Issue identification paper: Drug-device combination …

(Just Now) WebObjective. This paper is intended to identify the key challenges associated with Health Canada's oversight of drug-device combination products (DDCPs) as per …

https://www.canada.ca/en/health-canada/programs/consultation-issue-identification-paper-drug-device-combination-products-draft/document.html

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Consultation on the Issue identification paper: Drug …

(1 days ago) WebThis consultation ran from April 6, 2021 to June 7, 2021. See the “What we heard” report for summaries of the discussions that took place. Drug-device …

https://www.canada.ca/en/health-canada/programs/consultation-issue-identification-paper-drug-device-combination-products-draft.html

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Guidance on Medical Device Establishment Licensing …

(1 days ago) WebHealth Canada April 1, 2020 April 1, 2020 Guidance on Medical Device Establishment Licensing and Medical Combination products A combination product is a …

https://publications.gc.ca/collections/collection_2020/sc-hc/H14-334-2019-eng.pdf

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Combination Products - Canadian Clinical Drug Data Set

(3 days ago) WebCombination Products Introduction and Requirement. A Combination Product is one that consists of more than one component part, commonly known as a …

https://infoscribe.infoway-inforoute.ca/display/CCDD/Combination+Products

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Health Canada Approves KEYTRUDA® in combination …

(7 days ago) WebApproval is based on the Phase 3 KEYNOTE-811 Trial. KIRKLAND, QC, February 6, 2024 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced …

https://www.merck.ca/en/newsroom/health-canada-approves-keytruda-in-combination-with-trastuzumab-and-chemotherapy-as-a-first-line-treatment-for-patients-with-locally-advanced-unresectable-or-metastatic-her2-positive-gastric-or/

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Drug/Medical Device Combination Products - Open Government

(5 days ago) WebThe purpose of this policy is to ensure timely access to drug/medical device combination products by establishing a single window approach and more efficient …

https://open.canada.ca/data/en/dataset/1e840214-3367-40fa-b713-f70d4be8340a

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Proposed Regulation/Guidance Document

(1 days ago) WebPage 1of 11. ISPE. 6110 Executive Blvd., Suite 600, North Bethesda, MD 20852 USA T 1 301-364-9201 F 1 240-204-6024 ispe.org. Proposed Regulation/Guidance Document: …

https://ispe.org/sites/default/files/regulatory/ISPE-Commenting/2021/ISPECommentsHealthCan2021-07.pdf

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Drug-Device Combination Products under MDR BSI Canada

(3 days ago) WebIntroduced by the European Commission under the Medical Devices Regulation (MDR), Article 117 requires manufacturers placing drug-device combination products onto the …

https://www.bsigroup.com/en-CA/Medical-Devices/Technologies/drug-device-combination-products/

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Health Products and Food Branch - PDA

(Just Now) Webcombination products in recent years While their legal frameworks . for these combination products may differ slightly from Canada’s, key elements are …

https://www.pda.org/docs/default-source/website-document-library/scientific-and-regulatory-affairs/regulatory-comments-resources/2021/pda-comments-to-health-canada-issue-identification-paper---drug-device-combination-products-21-july-2021.pdf?sfvrsn=cee16881_2

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Sponsored Webcast: Combination Products: Regulatory Approach …

(1 days ago) WebThis webinar will walk you through the regulatory approach and the new regulations applied for combination products.

https://www.raps.org/products/sponsored-webcast-combination-products-regulatory-approach-and-cgmp-requirements--on-demand

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Regulatory Affairs for Combination Products - Frontiers

(3 days ago) WebCombination products are medical products that combine two or more different product types, including drugs, devices, or biological products, into a single entity. Similarly, …

https://www.frontiersin.org/research-topics/57767/regulatory-affairs-for-combination-products

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Current state of Health Canada regulation for cellular and gene …

(7 days ago) WebThere is no formal regulatory definition of cell therapy in Canada, and cell therapies are not specifically listed in the Food & Drugs Act [3].CGTPs in Canada may …

https://www.sciencedirect.com/science/article/pii/S1465324919300416

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WebHealth Canada. Products authorized under Health Canada’s NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely

https://pdf.hres.ca/dpd_pm/00066254.PDF

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Combination Products: A Growing Trend in Health Technology

(8 days ago) WebWhen a drug or biologic is combined with a medical device, for example, that might be considered a combination product. A drug prefilled syringe is a …

https://array.aami.org/content/news/combination-products-growing-trend-health-technology

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Health Canada and FDA eSTAR Pilot FDA

(2 days ago) WebUpdate: Request for participation in the Health Canada (HC) and Food and Drug Administration The medical device must not be an in-vitro diagnostic device, a …

https://www.fda.gov/medical-devices/how-study-and-market-your-device/health-canada-and-fda-estar-pilot

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Quality documentation for medicinal products when used with a …

(5 days ago) WebKeywords: Medical device, medicinal products, Article 117, Notified Body opinion, Integral, Co-packaged, Referenced Current version - effective from 1/01/2022 …

https://www.ema.europa.eu/en/quality-documentation-medicinal-products-when-used-medical-device-scientific-guideline

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Combination Products FDA

(Just Now) WebActs, Rules and Regulations. Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products.

https://www.fda.gov/combination-products

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Partial substitutions of animal with plant protein foods in - Nature

(Just Now) WebCanada’s Food Guide recommends greater consumption of plant protein foods, but replacing animal with plant protein sources might have important …

https://www.nature.com/articles/s43016-024-00925-y

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Combined Canada Introduces New Critical Illness Suite of Products

(9 days ago) WebMARKHAM, ON, May 1, 2024 /PRNewswire/ -- Combined Canada, a leading provider of supplemental accident, health, disability, and life insurance products in …

https://finance.yahoo.com/news/combined-canada-introduces-critical-illness-121000553.html

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