Health Canada Combination Products

Listing Websites about 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 … 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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Health Canada: Issue Identification Paper: Drug-Device …

(1 days ago) WEBHealth Canada: Issue Identification Paper: Drug -Device Combination Products (DDCPs) Draft for Consultation . draft dated 2021/05/10. Comments from: International Society for …

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

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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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Drug/Medical Device Combination Products - Open …

(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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Regulatory perspectives of combination products - PMC

(3 days ago) WEBCombination products. “ The products marketed as a single drug, medical device, or cellular and tissue-based product that combine two or more types of drug, …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8637005/

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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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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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OPSYNVI® (macitentan and tadalafil) Becomes the First and Only …

(8 days ago) WEBHealth Canada’s approval is based on three comparative bioavailability studies, which demonstrated the bioequivalence of a single dose of macitentan 10 mg …

https://www.jnj.com/media-center/press-releases/opsynvi-macitentan-and-tadalafil-becomes-the-first-and-only-health-canada-approved-once-daily-fixed-dose-combination-treatment-for-patients-with-pulmonary-arterial-hypertension-pah

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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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Drug and Medical Device Combination Product Decisions

(9 days ago) WEBdental products impregnated with a drug whose primary purpose is to deliver a drug. red blood cell processing solutions. contrast media. peritoneal dialysis solutions. alcohol …

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/combo_mixte_dec_pol-eng.pdf

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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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Frequently Asked Questions About Combination Products FDA

(1 days ago) WEB1. A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, …

https://www.fda.gov/combination-products/about-combination-products/frequently-asked-questions-about-combination-products

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Health Canada Approves KEYTRUDA® for adult patients with

(9 days ago) WEBHealth Canada Approves KEYTRUDA® for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma, in combination with …

https://www.newswire.ca/news-releases/health-canada-approves-keytruda-r-for-adult-patients-with-locally-advanced-unresectable-or-metastatic-biliary-tract-carcinoma-in-combination-with-gemcitabine-based-chemotherapy-813098991.html

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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 Guidance Documents FDA

(2 days ago) WEBCategory Title Type Date; Pre-market: Principles of Premarket Pathways for Combination Products: Final: 1/2022: Pre-market: Requesting Food and Drug …

https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents

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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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RESPIRATORY MEDICATIONS FOR INHALATION AVAILABLE IN …

(4 days ago) WEB60. Aerolizer. No dose counter (capsule inserted into the device) Formoterol (Oxeze ) 6 or 12 mcg; 60. Turbuhaler. A red mark shows in the window underneath the mouthpiece …

http://hcp.lunghealth.ca/wp-content/uploads/2020/12/Respiratory_Inhaled_Medication_Products-February-12-2019-1.pdf

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