FDA review of Covid-19 vaccines for school-age children and other pandemic matters would likely weather a government shutdown without interruption, but other high stakes work could fall to the wayside. The Department of Health and Human Services said it will use the full extent of existing authorities to keep the Covid-19 response going in the event of…
US Food & Drug Administration Oncology Center of Excellence Director Richard Pazdur thinks the time is right to simplify the number of “expedited” pathways that FDA and drug sponsors use as part of the regulatory process. Pazdur has emphasized that point as part of an initiative launched by Friends of Cancer Research last fall to…
The US Food & Drug Administration sounds ready to test the idea of having sponsors submit a high-level overview of plans and objectives in specific drug development areas like dosing as a mechanism to further improve interactions to support “Breakthrough” drug development. The proposal to pilot test “Drug Development Snapshots” as a new communication tool…
President Biden’s failure to name someone to lead the Food and Drug Administration, more than 10 months after the election, has flummoxed public health experts who say it’s baffling for the agency to be without a permanent leader during a national health crisis. The pandemic has taxed the FDA, an 18,000-person agency whose chiefs have…
The US Food and Drug Administration is asking cancer drug sponsors to think about the studies intended to support accelerated approval, as well as those aimed at confirming clinical benefit postapproval, as a single package when bringing their development plans to the agency. The goal is to have an early, comprehensive discussion with the agency…
In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval. The research comes as the FDA is at…
Eliminating inequities in health care is an important priority. One persistent inequity involves the lack of data to guide cancer care for older adults. Although clinical trials provide the strongest foundation for acquiring such data, a recent analysis by the Food and Drug Administration (FDA) found that only 24% of patients enrolled in trials supporting…
While groups expressed overwhelming support for the US Food and Drug Administration’s (FDA’s) draft guidance expanding eligibility criteria for investigational oncology trials, some comments discouraged the agency from taking an approach that dichotomizes the curative and non-curative setting; a pharmaceutical firm suggested that safety data be combined for some investigations performed in curative and non-curative…
Circulating tumor DNA, tumor mutational burden, and homologous recombination deficiency are 3 emerging biomarkers for tailoring therapy need further clinical and technical clarity to support robust use in daily practice. Although the precision medicine era is in full swing in oncology, 3 emerging biomarkers for tailoring therapy need further clinical and technical clarity to…
WASHINGTON — For most of its history, the Food and Drug Administration’s shortcut pathway for approving certain medicines was hardly contentious among anyone but the most diehard agency nerds; for years, only a handful of drug makers even used it. Now, however, just as the accelerated approval program is reaching peak popularity, key supporters, including Oncology Center…
