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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. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. Food and Drugs Act , R.S.C.,

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

According to Dr Mansoor Amiji of Northeastern University: “Instead of relying on product quality as a readout after the product is made, you start to implement these procedures into the product production processes. Practising QbD in biosimilar product development.

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Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . It’s primarily the FDA’s role over drug safety and quality that captures my interest and admiration.”.

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Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard.

Drugs 71
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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. Hospital products, which grew 10% operationally to $2.3 Hospital products, which grew 10% operationally to $2.3 percentage points of operational growth.

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COVID-19 Pandemic Coverage

XTalks

production and that treatment with this new drug may boost the lung’s antiviral defenses against the virus. In the US, it’s still a patchwork productions approach to mask-wearing but slowly – too slowly, given the surge of new coronavirus cases in recent weeks – more and more US states are implementing mandatory mask requirements.