May 9, 2022 – New analyses of clinical trials conducted in the United States and in Europe on potential new drugs found that not only were study populations not as diverse as the general population, but that frequently no race or ethnicity data was included in the trial reports, and sometimes not even gender data. […]
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March 21, 2022 – Pros and cons of the FDA’s accelerated approval pathway took center stage at a House Energy and Commerce Committee meeting held last week. While a slate of health-related bills for possible inclusion in the Prescription Drug User Fee Act (PDUFA VII) reauthorization package were discussed, the hearing led off with arguments […]
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Feb. 21, 2022 – During President Joe Biden’s first year in office, his administration’s health policy team has faltered, made missteps and miscalculations on COVID-19 decisions and communication, and took more than a year to secure a permanent Food and Drug Administration Commissioner (Robert Califf, M.D., was confirmed to take the helm on Feb. 15). […]
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Feb. 7, 2022 – Although the nomination of Dr. Robert Califf to return as FDA Commissioner was advanced by the Senate House, Education, Labor, and Pensions (HELP) Committee just weeks ago and it appeared Califf was poised to be confirmed by the full Senate, new opposition to his nomination reportedly has switched at least some […]
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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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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 […]
Read more Dec. 20, 2021 — Dr. Robert Califf, President Joe Biden’s nominee for the FDA Commissioner position, spent roughly two hours answering questions volleyed his way during last week’s Senate Health, Education, Labor, and Pensions (HELP) Committee’s hearing on his nomination. Califf’s answers, peppered with details, facts and figures, references to senators’ home-state concerns, anecdotes about […]
Read more Nov. 15, 2021 – Many in the healthcare space are breathing a sigh of relief that President Joe Biden finally announced his nominee to be the new FDA Commissioner on Nov. 12: former FDA Commissioner Robert Califf, M.D. Although Coalition for Healthcare Communication Executive Director Jon Bigelow believes Califf will win Senate confirmation for a […]
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Oct. 21, 2021—Nine months into President Joe Biden’s administration, he has still not nominated a candidate to take the helm at the Food and Drug Administration (FDA). Amid the COVID-19 pandemic and other pressing healthcare issues, the pressure is rising for a permanent FDA commissioner, but many of the frequently-named frontrunners for the position appear […]
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