March 14, 2021 – Nearly a month after being sworn in for the second time as Food and Drug Administration (FDA) Commissioner, Robert Califf, M.D., has a lot on his plate, including the ongoing COVID-19 pandemic — and lessons learned about processes and the harms of misinformation – as well as a call for clinical […]
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Jan. 10, 2022 – The Food and Drug Administration’s (FDA’s) ability to catch up with its inspection backlog caused by the COVID-19 pandemic is slowing again after the FDA temporarily postponed many inspectional activities in the United States through Jan. 19 and deferred foreign inspection assignments that were slated for February 2022. According to an […]
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Dec. 6, 2021 – As the seemingly fast-spreading COVID-19 omicron variant begins to show up in the United States, the Food and Drug Administration (FDA) is taking measures now to meet any potential need for new diagnostics, vaccines and therapeutics to combat the next phase of the pandemic. On Dec. 2, President Joe Biden announced […]
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Nov. 29, 2021 –With little fanfare, the U.S. Department of Health and Human Services (HHS) recently moved to allow licensed pharmacists to dispense Food and Drug Administration (FDA)-authorized COVID-19 therapeutics directly to patients, without a physician prescription. This step, taken by publishing an amendment to a declaration under the Public Readiness and Emergency Preparedness Act, […]
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Nov. 22, 2021 – As the COVID-19 pandemic continues, the American Medical Association (AMA) is stepping up efforts to stop the dangerous spread of information, particularly when it comes from healthcare professionals (HCPs) who are using their licenses to validate the disinformation they are spreading. This scenario – where HCPs deliberately make false claims about […]
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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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March 8, 2021 – Pharmaceutical companies and other healthcare stakeholders who utilize programmatic advertising are unintentionally placing ads that promote COVID-19 vaccines, vaccine distribution and safe pandemic practices on websites that are spreading false health information, according to a recent report from Newsguard. “Throughout the pandemic, many of the world’s largest and most trusted brands […]
Read more Feb. 23, 2021 – Amid a surge in opioid overdose deaths over the past year – due in part to the ongoing COVID-19 pandemic and its corresponding isolation and lack of employment and support services – the FDA’s Office of Prescription Drug Promotion (OPDP) has asserted the agency’s “ongoing commitment to combat inappropriate opioid use.” […]
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Feb. 8, 2021 – With growing concern about the spread of new COVID-19 variants, companies developing vaccine modifications will not have to “start at square one,” according to Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock, M.D.. Because of early indications that the initial vaccines may have lower effectiveness against one or more of […]
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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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