Jan. 24, 2022 – With the COVID-19 pandemic heading into year three, the Food and Drug Administration (FDA) faces ongoing challenges but continues to work on four primary agency priorities, according to Nancy Bradish Myers, president of Catalyst Healthcare Consulting, who spoke at a Jan. 21 Coalition for Healthcare Communication webinar, “A New Start for […]
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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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Dec. 13, 2021 – Recent FDA Warning Letters calling out promotional claims made about vaping products are interesting in that they were issued not by the agency’s Center for Tobacco Products, but by the Center for Drug Evaluation and Research (CDER). “Although the FDA has been criticized for missing deadlines on approving or rejecting various […]
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June 11, 2021 – The Food and Drug Administration (FDA) “is really central, not only to product approvals, but to what [medical product companies] can say in terms of marketing,” according to Prevision Policy Senior Editor Kate Rawson. Rawson, who spoke June 4 at a Coalition for Healthcare Communication (CHC) webinar, “What’s Ahead for the […]
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June 7, 2021 — Despite ongoing speculation about who will be the next Commissioner of the Food and Drug Administration (FDA), “the real leadership story is at CDER,” the Center for Drug Evaluation and Research, according to Kate Rawson, senior editor of Prevision Policy. As Rawson explained during a June 4 webinar on “What’s Ahead […]
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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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Jan. 18, 2021 – Under the Biden administration, longtime Center for Drug Evaluation and Research (CDER) director and FDA veteran Janet Woodcock, M.D., has been tapped to serve as the acting commissioner of the Food and Drug Administration (FDA) after current FDA Commissioner Stephen Hahn, M.D., stepped down on Jan. 20. Media reports suggest that […]
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Jan. 11, 2021 – When considering all of the COVID-19 challenges the FDA faced in 2020, it is noteworthy that the Center for Drug Evaluation and Research (CDER) approved 53 novel drugs last year, the second highest number of novel drug approvals in the past 10 years. In a forward to CDER’s 2020 report on […]
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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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May 6, 2019 — “It doesn’t just take a village, it takes an ecosystem,” Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health (CDRH), told the annual meeting of the Reagan-Udall Foundation for the FDA in Washington on May 2, highlighting the challenge of drawing upon a sufficiently broad range of […]
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