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Dormant drug status can trigger generic access to an alternate Canadian Reference Product

Pharma in Brief

On 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 ). For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”.

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Gelteq IPO: Supporting Gel Technology for Oral Drug Delivery

XTalks

Gelteq centers its technology on a proprietary, customizable gel platform designed for precise drug delivery, supporting prescription drugs, nutraceuticals, pet care and sports supplements. Across the industry, recent innovations in drug delivery signal a creative shift towards ease of administration and expanded treatment options.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?

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The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

Delveinsight

Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Smoking Cessation: What are the drugs available in the market? The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. However, it is possible.