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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April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […]
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Nov. 8, 2019 – The FDA announced this week that it has reorganized its office that reviews applications for new and existing cancer therapies; its Office of Hematology Oncology Products has been renamed the Office of Oncologic Diseases (OOD) and has six divisions to accommodate a more streamlined drug review process, according to a Nov. […]
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April 11, 2017 – There is no doubt that the Trump administration is likely to change health policy in the near future, but the questions that remain to be answered are exactly what those changes will be and how they will affect healthcare communication. For predictions and insight from an expert panel of FDA and […]
Read more March 8, 2017 – In an open letter to President Donald Trump, Pharmalot’s Ed Silverman asks that before Trump criticizes and plans any reform of the Food and Drug Administration (FDA), he should take a hard look at how the agency has performed in recent years. “During the past decade, the FDA has increasingly used […]
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