Generic Drugs Regulation Sales 
Pharma in Brief
AUGUST 9, 2021
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.,
Camargo
NOVEMBER 11, 2020
Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product. Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks.
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Pharmaceutical Technology
NOVEMBER 21, 2022
Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 billion) in total sales in 2021 and is expected to grow 1.1% Among the 37 member companies, 17 of them are overseas companies and 20 of them are Japanese companies with a 10%+ overseas pharma sales ratio.
Pharmaceutical Technology
NOVEMBER 21, 2022
Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 billion) in total sales in 2021 and is expected to grow 1.1% Among the 37 member companies, 17 of them are overseas companies and 20 of them are Japanese companies with a 10%+ overseas pharma sales ratio.
Pharma in Brief
FEBRUARY 8, 2024
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]”.
pharmaphorum
JULY 29, 2021
The drugmaker specialises in selling generic drugs that are hard to manufacture, which places a barrier to widespread generic competition. The regulator said that in addition to the fines, the NHS may choose to pursue the companies for damages in the courts. ” Advanz itself was directly fined £40.9 million and £51.9
Pharmaceutical Technology
JULY 10, 2008
As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. The report says the infrastructure around regulators vendors and the support industry will have to significantly change.
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