Drug And Health Submissions Canada

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Drug and Health Product Submissions Under Review (SUR)

(3 days ago) The Submissions Under Review (SUR) Lists include submissions filed under the Food and Drug Regulationsfor use in relation to the COVID-19 pandemic. These submissions are identified under the submission 'class' column. To find these submissions, type "COVID" into the "Filter items" box at the top of … See more

https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review.html

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Guidance Document: The Management of Drug Submissions and …

(8 days ago) WEBIn order to maintain consistency and enhance transparency, this guidance was updated in July 2019 to reflect the most current information, processes and …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/document.html

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Management of Drug Submissions and Applications - Canada.ca

(Just Now) WEBArchived Versions. Management of Drug Submissions [2019-07-25] Date modified: 2021-05-26. Guidance Documents – Applications and submissions – Drug …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions.html

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Guidance for Industry Preparation of the Quality Information …

(2 days ago) WEBTechnical Document‐ Quality Questions and Answers/ Location Issues, as well as the Health Canada Guidance documents for Industry on the preparation of various types of …

https://publications.gc.ca/collections/collection_2019/sc-hc/H164-242-2018-eng.pdf

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Drug and Health Product Submissions Under Review (SUR)

(2 days ago) WEBContact Email: [email protected] Keywords: Drug submission; submissions under review; drug and health product review and approval. Subject: Health and …

https://open.canada.ca/data/en/info/40b5d9f7-fafc-4a51-8fd9-7847a41401f8

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Guidance document : management of drug submissions and …

(1 days ago) WEBOttawa, ON : Health Canada = Santé Canada, July 2021. ©2021 : Description : 1 online resource (72 pages) ISBN : 9780660393704 : Catalogue number : H164-277/2021E-1 …

https://publications.gc.ca/site/eng/9.901130/publication.html

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Drug and Health Product Submissions Under Review (SUR)

(5 days ago) WEBHow to access lists of drug submissions currently under review, and lists of certain drug submissions formerly under review. This initiative is funded by Health Canada's …

https://www.substanceusehealth.ca/resource/drug-and-health-product-submissions-under-review-sur

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Health Canada's Proposal to Accelerate New Drug Reviews

(3 days ago) WEBHealth Canada began a regulatory review of drugs and devices in 2017, and as part of this process, it issued a “Draft Guidance: Accelerated Review of Human Drug …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7294445/

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Publication of the Health Canada Guidance Document: Quality …

(2 days ago) WEBPublication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New …

https://open.canada.ca/data/en/info/89e44fc0-5ead-423b-a518-b6bf2e604c02

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Health Canada updates Guidance Document: The Management of …

(9 days ago) WEBAuthored by Katie Lee. September 30, 2019. On July 25, 2019, Health Canada released an updated version of the Guidance Document: The Management of …

https://www.smartbiggar.ca/insights/publication/health-canada-updates-guidance-document-the-management-of-drug-submissions-and-applications

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New drug submissions in Canada and a comparison with the Food …

(3 days ago) WEBHealth Canada considered New Drug Submissions for 272 NAS from December 2015 until the end of 2022 and approved 257 of them. Fifteen NAS were not …

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0286802

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The Pathway for New Cancer Drug Access in Canada - PMC

(3 days ago) WEBThe Health Products and Food Branch (HPFB) is the section of Health Canada that reviews a new drug seeking market access when a formal “New Drug …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8870298/

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Guidance Document

(2 days ago) WEBfrom the information or material contained in the new drug submission, extraordinary use new drug submission, abbreviated new drug submission or abbreviated extraordinary …

https://publications.gc.ca/collections/collection_2021/sc-hc/H13-9-31-2019-eng.pdf

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Health Canada: Guidance Document Management of Drug …

(9 days ago) WEBHealth Canada on August 2, 2022, revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA).This guidance …

https://www.regulatoryaffairsnews.com/post/health-canada-guidance-document-management-of-drug-submissions-and-applications-post-din-changes

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Management of Drug Submissions - FDAnews

(6 days ago) WEBThe benefits of the Guidance document for the Management of Drug Submissions include: Assisting sponsors with acceptable practices, performance targets and access to …

https://www.fdanews.com/ext/resources/files/01/01-13-CanadianSubmissions.pdf

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New Drug Submission (NDS) for Canada - Freyr Solutions

(2 days ago) WEBHealth Canada’s New Drug Submission (NDS) is the process through which new drugs are approved and controlled by the Canadian Health Authority before entering the …

https://regulatoryaffairs.freyrsolutions.com/new-drug-submission-nds-health-canada

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Ontario warns Toronto Public Health to drop drug - MSN

(9 days ago) WEBOntario warns Toronto Public Health to drop drug decriminalization application. The city sent a preliminary request to Health Canada in January 2022 and, after more …

https://www.msn.com/en-ca/health/other/ontario-warns-toronto-public-health-to-drop-drug-decriminalization-application/ar-BB1mvYP2

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Uncertainty clouds Toronto's bid to decriminalize drugs

(9 days ago) WEBThe city made a request to Health Canada in early 2022 for an exemption under the Controlled Drugs and Substances Act. That application was put back under …

https://www.cbc.ca/news/canada/toronto/toronto-drug-decriminalization-1.7199990

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Ontario warns Toronto Public Health to drop drug …

(8 days ago) WEBOntario has warned Toronto Public Health's top doctor to drop the city's drug decriminalization application with Health Canada. updated its submission in March …

https://globalnews.ca/news/10500150/ontario-warns-toronto-drop-drug-decriminalization-application/

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Drug and Health Product Submissions Under Review (SUR): New …

(2 days ago) WEBdrug-and-health product submissions; Submissions Under Review; SUR; new-drug submissions under-review; Subject: Health and Safety; Maintenance and …

https://open.canada.ca/data/en/info/80106243-6653-4c95-96a0-ee093ea71cbf

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Ford calls on Ottawa to end approvals for safe drug supply sites

(7 days ago) WEBFord's letter comes a day after Ontario's minister of health and solicitor general warned Toronto Public Health to drop its bid to decriminalize drugs for personal …

https://www.cbc.ca/news/canada/toronto/safe-supply-drugs-ontario-ford-trudeau-1.7207421

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Toronto’s denied drug decriminalization is a step ‘backwards,’ …

(1 days ago) WEBIn 2023, 2,551 drug deaths in B.C. were linked to the unregulated market — a record high for the province. In the first three months of 2024, drug deaths have been …

https://globalnews.ca/news/10505189/ottawa-toronto-drug-decriminalization-rejection-canada/

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Ottawa rejects Toronto's request to decriminalize drug possession

(6 days ago) WEBThe city sent its proposal to Health Canada in January 2022 and, after more consultations, updated its submission in March 2023. The proposal called for decriminalization to be …

https://www.msn.com/en-ca/news/other/news-notification/ar-BB1mABRY

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Drug and Health Product Submissions Under Review (SUR): …

(2 days ago) WEBSubmissions formerly under review: Supplemental new drug submissions for new uses Publisher - Current Organization Name: Health Canada Licence: Open …

https://open.canada.ca/data/en/info/917dc978-8284-4c2c-8d50-39ab978b3e57

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Government of Canada supports development & point-of-care …

(6 days ago) WEBMay 17, 2024 Ottawa, Ontario Public Health Agency of Canada. In Canada and across the world, microbes that cause infections are becoming increasingly resistant …

https://www.canada.ca/en/public-health/news/2024/05/government-of-canada-supports-development--point-of-care-dissemination-of-national-antimicrobial-prescribing-guidelines.html

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MAPS psychedelics research for MDMA therapy comes under …

(4 days ago) WEBThe organization also barred the two therapists from becoming providers of MDMA-assisted therapy in affiliation with MAPS, and health authorities were notified in …

https://www.npr.org/sections/health-shots/2024/05/13/1250580932/ecstasy-mdma-ptsd-fda-approval

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Canada Re-Criminalizes Public Drug Use in British Columbia

(5 days ago) WEBThe government of Canada on Tuesday walked back part of a program allowing people in British Columbia to possess small amounts of drugs, including heroin …

https://www.nytimes.com/2024/05/07/world/canada/british-columbia-public-drug-use.html

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Eisai starts rolling submission for injectable version of Alzheimer's

(Just Now) WEBEisai and partner Biogen said on Tuesday that the Japanese drugmaker has begun submitting data on a rolling basis to the US health regulator for a marketing …

https://www.reuters.com/business/healthcare-pharmaceuticals/eisai-starts-rolling-submission-injectable-version-alzheimers-drug-with-us-fda-2024-05-14/

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Calls for evictions, threats of vigilantism over drug activity at

(Just Now) WEBThere were 53 suspected drug-related deaths in the health unit's catchment area last year and 17 suspected deaths More than 1 in 4 deaths among young people …

https://www.cbc.ca/news/canada/thunder-bay/kenora-drug-crisis-concerns-1.7204051

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With prescription drug bills, Vermont lawmakers hope to lower

(4 days ago) WEBVermont lawmakers are hoping that new legislation headed to the desk of Gov. Phil Scott will help patients afford prescription drugs, as rising pharmaceutical …

https://www.allsides.com/news/2024-05-21-0320/healthcare-prescription-drug-bills-vermont-lawmakers-hope-lower-pharmaceutical

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Drug and Health Product Submissions Under Review (SUR): New …

(2 days ago) WEBContact Email: [email protected] Keywords: drug-and-health product submissions; submissions under review; SUR; new-drug submissions …

https://open.canada.ca/data/en/info/75f76896-b4c1-44af-bfed-edeee0eee3a1

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Wegovy users keep weight off for four years, Novo Nordisk study …

(5 days ago) WEBPatients taking Novo Nordisk's Wegovy obesity treatment maintained an average of 10% weight loss after four years, potentially boosting the drugmaker's case …

https://www.reuters.com/business/healthcare-pharmaceuticals/wegovy-weight-loss-sustained-four-years-trial-novo-nordisk-says-2024-05-13/

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