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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. Manufacturing Controls. On-site Evaluations.

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

Pharmacy Checkers

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” Clearly, the FDA acknowledges the relative strength of the EU on drug safety. Why do I write “exact same”?

Drugs 71
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COVID-19 Pandemic Coverage

XTalks

trillion) agreement reached in late July between leaders of the 27 countries in the European Union, a truly historic stimulus package designed to rescue flailing economies from COVID-19. The package is made up of a €390 billion fund in grants and a €360 billion in low interest loans. And stimulus packages continue.