Executive Summary FDA says it will not be ‘held hostage’ by its list of molecular targets, but patient advocates worry agency will be deterred from requiring assessments for targets not on the list, while industry worries about being surprised by demands for pediatric data. The US FDA is promising to take a flexible, transparent…
Friends of Cancer Research will host a meeting today to discuss the types of drugs that would likely need to be studied in pediatric cancer patients under a provision in last year’s FDA Reauthorization Act, S. 934 (115). While drug companies with new applications have long been required to study those medicines in children, the…
Reproduced with permission from Medical Devices Law & Industry Report, 27 MELR (Feb. 14, 2018). Copyright 2018 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>
FDA advocates on all sides applauded the request to increase funding significantly for FDA under the Trump administration’s budget for fiscal year 2019, which seeks more than $400 million in additional outlays for oversight of drugs, biologics and medical devices. The Alliance for a Stronger FDA praised the budget plan for recognizing the important work…
President Donald J. Trump raised the national profile of controversial “right-to-try” legislation by throwing his support behind it during his recent State of the Union Address. The legislation would let dying patients access experimental therapies with minimal US Food and Drug Administration (FDA) involvement, and with the president’s backing supporters are hopeful that their…
Executive Summary President Trump’s FY 2019 budget request includes $473m in new non-user fee revenue for the US agency, a reversal of the previous year’s request. President Trump offered FDA a bounty of potential new funding in his fiscal year 2019 budget request, most it not from user fees, although it is largely unclear…
The Trump administration’s fiscal 2019 budget allocates $20 million to FDA’s Oncology Center of Excellence, a pleasant surprise for Friends of Cancer Research (Friends), the organization that has been involved with OCE from its inception. Despite the proposed budget boost for the center, cancer patient advocacy groups are still concerned with overall cuts to the…
Oncology drug labels, especially those that have been on the market for more than 15 years, may not always be up-to-date. Critical data about safety, efficacy, or prescribing information may be missing. Modernizing the labeling process can correct inaccurate information, add data for indications beyond initial approval, remove impediments to reimbursement where labeling is used…
Executive Summary MedPAC meeting elicits negative view of designation from one members and no one disagreed. Should US FDA reiterate what the special designation actually means? It may be time for the US FDA to reiterate to the public the high standard for granting a “Breakthrough Therapy” designation to a promising therapy in development. …
