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. 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. 25, 2021 – Translating real-world data (RWD) into a standard format that the Food and Drug Administration (FDA) can process, review and archive will pose challenges that are best met with detailed documentation of a sponsor’s data approach, according to the agency’s draft guidance on data standards for drug and biological products submissions containing […]
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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 […]
Read more Oct. 11, 2021 – The Food and Drug Administration (FDA) will hold a virtual public meeting Nov. 2 to discuss the proposed changes it would like to make during the reauthorization process for the Biosimilar User Fee Act for fiscal years 2023 through 2027 (BsUFA III). The current legislation, BsUFA II, will expire in September […]
Read more Oct. 4, 2021 – As part of its real-world evidence (RWE) program, the Food and Drug Administration last week issued a draft guidance to provide sponsors, researchers and other stakeholders with the agency’s current thinking about the use of electronic health records (EHRs) or medical claims data in clinical studies “to support a regulatory decision […]
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Sept. 27, 2021 – In the midst of public scrutiny regarding clinical trial transparency, the Food and Drug Administration (FDA) and the United Kingdom’s Health Research Agency (HRA) recently took actions that may indicate their increased willingness to more closely monitor clinical investigators who do not report trial results in a timely manner. “Pharma, researchers, […]
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Sept. 20, 2021 – Six out of 18 cancer drugs that initially received accelerated approval from the FDA have indications that remain on the labeling and continue to be recommended in clinical guidelines despite post-approval trials demonstrating no improvement in the primary endpoint, according to a retrospective observational study published Sept. 9 by BMJ. “The […]
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Sept. 10, 2021 – The Food and Drug Administration (FDA) recently issued a commitment letter regarding the next iteration of the Prescription Drug User Fee Act (PDUFA VII) that spells out its review timeframes, performance goals and modernization priorities for fiscal years (FYs) 2023-2027. Among these priorities are enhancements related to expediting drug development, expanding decision […]
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