Tag: BLA

BLA

Regulatory/FDA

CDER Approves 27 Novel Drugs in First Half of 2021

CDER Approves 27 Novel Drugs in First Half of 2021

July 12, 2021 – The COVID-19 pandemic did not slow down the drug approval process for the FDA’s Center for Drug Evaluation and Research (CDER) in 2020 – a year that saw CDER approve the second-highest number of new molecular entities (NMEs) – and that pace seems to be holding steady in 2021, with CDER […]

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Washington Focus

Rawson Previews Biden COVID-19 Approach and Vaccine Roll-out

Rawson Previews Biden COVID-19 Approach and Vaccine Roll-out

Nov. 30, 2020 – Job one for President-elect Joe Biden is the response to the COVID-19 pandemic, which will represent a “marked difference in energy and tone” than that offered by the current administration and likely will include a new FDA Commissioner as well as the roll-out of COVID-19 vaccines, according to Kate Rawson, senior […]

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