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FDA generic drug approvals rose in 2023 in bid for improved access

Pharmaceutical Technology

The FDA Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.

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Influencers of Generic Drug Utilization

Drug Patent Watch

In a systematic review titled “Influencers of Generic Drug Utilization,” researchers aimed to shed light on the key factors influencing the use of generic prescription drugs in the United States.… The post Influencers of Generic Drug Utilization appeared first on DrugPatentWatch - Make Better Decisions.

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CpHI Europe: Quality improvements key for the surviving the generic drugs market

Pharmaceutical Technology

Experts discuss the key trends in quality improvements and API reshoring for the generic drugs market at CpHI Europe.

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Factors that May Predict the Likelihood of Generic Drug Marketing Applications

Drug Patent Watch

The FDA conducted a study to identify factors that may predict the likelihood of generic drug marketing applications.

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Health Canada disclosing more information on pending generic drug submissions

Pharma in Brief

On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. In Canada, the ANDS pathway is used to review and approve generic prescription drugs (but not biosimilars).

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STAT+: AAM’s Dan Leonard, president of generic drug lobby, ousted

STAT News

The generic drug industry’s lobbying group, the Association for Accessible Medicines, fired its president Dan Leonard, two sources familiar with the decision said Friday evening. It was not immediately clear why Leonard was fired, and AAM didn’t immediately respond to a request for comment.

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STAT+: Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access

STAT News

Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. For instance, a generic drug could be marketed to treat one type of heart problem, but not another.