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Florida approved to import Canadian prescription drugs

WEBOn January 5, 2024, the US Food and Drug Administration (FDA) approved Florida’s proposal to import prescription drugs from Canada.This is the first approval of a Section …

Actived: 3 days ago

URL: https://www.pharmainbrief.com/2024/01/florida-approved-to-import-canadian-prescription-drugs/

Health Canada reports on a national strategy for rare disease …

WEBHealth Canada has published a report on its public consultation on building a national strategy to address access to drugs for rare diseases. This report follows the …

Category: Health Go Health

What is a natural health product

WEBIn recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. The Courts’ decisions provide insight into …

Category: Health Go Health

Health Canada disclosing more information on pending generic …

WEBOn February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. Specifically, for generic …

Category: Health Go Health

Health Canada amends regulations to permit

WEBHealth Canada has finalized amendments to the Food and Drug Regulations (FDR) and Natural Health Product Regulations (NHPR) to allow for the distribution of samples of …

Category: Food Go Health

Drug price negotiations: pCPA Temporary Access Process launched

WEBThe pan-Canadian Pharmaceutical Alliance (pCPA) has launched its Temporary Access Process (pTAP) to facilitate early market access to new drugs that were assessed under …

Category: Health Go Health

Health Canada consulting on wide-ranging regulatory …

WEBHealth Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory …

Category: Food, Medical Go Health

Drug advertising: Updated guidance from Health Canada on the

WEBOn July 31, 2023, Health Canada published its updated Guidance on distinction between advertising and other activities for health products (the Distinction Guidance).The …

Category: Health Go Health

Pharma in Brief Norton Rose Fulbright LLP Pharmaceuticals

WEBOn January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP) in the Food and Drug Regulations ( Regulations ). The Notice advises that if an innovative drug is …. Pharma in Brief is written by Norton Rose Fulbright litigation and regulatory lawyers covering topics such

Category: Food Go Health

Health Canada releases updated Certificate of Supplementary …

WEBOn May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection (CSP Guidance).). The …

Category: Health Go Health

New Canadian Drug Agency formed, while National Pharmacare …

WEBThe Government of Canada has announced the creation of the Canadian Drug Agency (CDA).According to the government, the CDA “will provide the dedicated leadership and …

Category: Health Go Health

Health Canada consults on transition of interim order drugs, …

WEBAs we have previously reported, the Minister of Health (Minister) approved the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order for Drugs and Vaccines) on September 16, 2020 and the Interim order respecting the importation and sale of medical devices for use in relation to COVID …

Category: Medical Go Health

Health Canada’s proposed amendments to the Food and Drug …

WEBOn July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations (FDR) and the Medical Devices …

Category: Food, Medical Go Health

Health Canada consulting on clinical trial requirements and “new …

WEBAs we reported, the Budget Implementation Act, 2019 (BIA) paved the way for changes to the regulation of clinical trials and created a new class of “advanced …

Category: Health Go Health

Health Canada Provides Guidance on Regulation of Software as a …

WEBOn December 18, 2019, Health Canada published a new Guidance Document Software as a Medical Device (SaMD): Definition and Classification (Guidance Document).The …

Category: Medical Go Health

Federal Court finds that Health Canada breached procedural …

WEBOn August 8, 2023, the Federal Court overturned Health Canada’s decision that a cannabis product, Edison Jolts, was to be classified as edible cannabis and not cannabis extract.

Category: Health Go Health

Ontario introduces biosimilar transition policy Pharma in Brief

WEBOn December 20, 2022, the government of Ontario announced a new policy to expand the use of biosimilar drugs in the province. Patients receiving coverage

Category: Health Go Health

Health Canada issues Interim Order to address shortages of health …

WEBHealth Canada has published an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (the Interim Order ). This Interim Order allows Health Canada and the Canadian Food Inspection Agency to address critical supply issues in an expedited manner when shortages occur.

Category: Food, Medical Go Health

New interim order continues expedited authorization pathway for …

WEBThe Minister of Health has issued a new interim order regarding expedited authorizations for COVID-19-related medical devices. Interim Order No. 3 Respecting the Importation …

Category: Medical Go Health

Health Canada consulting on draft guidance distinguishing …

WEBHealth Canada is consulting on a draft guidance document entitled The Distinction Between Promotional and Non-promotional Messages and Activities for …

Category: Health Go Health