Jan. 4, 2022 – 2021 was a year of many healthcare challenges, but against this backdrop the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) approved 50 novel drugs and its Center for Biologics Evaluation and Research (CBER) approved 10 biological license applications (BLAs) (plus three source plasma products). CDER nearly […]
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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 […]
Read more April 6, 2021 – The FDA’s Center for Drug Evaluation and Research (CDER) approved 14 new molecular entities (NMEs) in the first quarter—up from 11 in the same span in 2020. According to AgencyIQ, this is a record for any first quarter in FDA history. Taken together with the 53 NMEs approved in 2020 (story […]
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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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March 7, 2018 – The Center for Biologics Evaluation and Research’s (CBER’s) Advertising and Promotional Labeling Branch (APLB) may not exactly be an enforcement powerhouse, issuing just three Untitled Letters since 2013, but it found fault with CSL Behring LLC’s Website, patient brochure, exhibit panel and sales aid for IDELVION® because these promotional materials allegedly […]
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