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Worldwide COVID-19 Vaccine Development – A Regulatory Perspective.

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Controlled Correspondence with FDA – An Update

Controlled Correspondence with FDA – An Update

The US Food and Drug Administration (FDA) has recently finalized its guidance to generic drug manufacturers on how to seek drug development information through the controlled correspondence (CC) …

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Generic Drug User Fee Amendments

The US generic drug industry has grown into a major component of health care, with generic drugs accounting for the vast majority of retail drug prescriptions dispensed. On …

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Impact of Brexit on the Pharmaceutical Industry

Impact of Brexit on the Pharmaceutical Industry

The pharmaceutical industry is one of the most important industries that will be directly impacted by Brexit. When the United Kingdom’s referendum was held in June 2016, the …

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