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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

On 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 Regulations in the spring of 2022. The amendments contemplate labelling flexibilities for special containers. Food and Drug Regulations , C.R.C., Public Comments.

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Top 15 Diabetes Drugs in 2023 by 2022 Sales Statistics

XTalks

Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, life sciences and pharmaceutical sectors. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5 billion in Q4 2022.

Sales 52
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Health Canada finalizes regulations relating to sale of unapproved drugs for emergency treatment under the Special Access Program

Pharma in Brief

Regulatory amendments to the Food and Drug Regulations ( FDR ) and the Natural Health Products Regulations ( NHPR ) were published in Canada Gazette (Part II) on October 14, 2020. any drug identification number or natural product number previously issued for the drug has not been cancelled for safety reasons.

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Health Canada releases updated Certificate of Supplementary Protection guidance

Pharma in Brief

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Certificate of Supplementary Protection Regulations , SOR/2017-165

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Eli Lilly Reaches Settlement with Totality MediSpa Over Sale of Compounded Mounjaro and Zepbound

XTalks

Lilly said it discovered some products claiming to be compounded tirzepatide medicines that contained bacteria, high impurity levels, different chemical structures and different colors than Mounjaro or Zepbound. “In In at least one instance, the product was nothing more than sugar alcohol,” said Lilly.

Sales 52
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Why Mask-Associated Dry Eye Won’t Necessarily Boost Restasis Sales

XTalks

Anti-inflammatory drugs like Restasis and Xiidra are popular treatment options for the condition, but will the emergence of mask-associated dry eye bolster their sales? But if you thought the growing number of patients presenting with mask-associated dry eye would mean higher sales for Restasis, think again.

Sales 119
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Food and Drug Regulations amended: COVID-19 drugs and vaccines transitioned out of interim order framework

Pharma in Brief

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Health Canada has also published a guidance document that contains additional information for drug sponsors.