Executive Summary Amid concerns Office of New Drugs reorganization will result in sponsors receiving conflicting advice, new director offers several items already contemplated to prevent such problems. The US FDA’s Office of New Drugs wants external stakeholder oversight to accompany standardization and other internal efforts to ensure reviewer consistency after its reorganization. Peter…
The National Cancer Institute (NCI) updated its clinical trial criteria to allow patients with specific health concerns to participate in NCI-funded clinical trials, as well as provide opportunities for patients younger than 18 years to take part in adult cancer trials. “NCI is extremely supportive of broadening eligibility criteria to make clinical trials more…
The National Cancer Institute (NCI) has revised its clinical trial protocol template to expand eligibility criteria for cancer clinical trials. The updated criteria will allow patients with certain health conditions to participate in NCI-funded trials, as well as provide opportunities for patients younger than 18 to take part in adult clinical trials under certain circumstances.…
The National Cancer Institute broadened the criteria for participation in NCI-funded clinical trials after meetings with cancer research organizations and the FDA. The new criteria expands eligibility to include patients with brain metastases, HIV/AIDS, chronic hepatitis B, organ dysfunction and a history of hepatitis C or cancers beyond the trial’s target. It also removes barriers…
Executive Summary Industry faces an uphill fight in a last-ditch effort to reverse the Medicare “donut hole” changes enacted at the start of 2018. At the same time, a stand-off over OTC monograph reform could have ripple effects on the plans to modernize the US An eleventh hour stand-off in the US Senate between…
Executive Summary US FDA and CMS explore reimbursement ideas to strengthen business case for antimicrobial development; new approval pathway likely is only needed in special situations. Bundle of money and pack of medication tablets or drug pills, close-up. Expensive health care concept, selective focus One of the US FDA’s newest weapons to help spur antimicrobial…
Executive Summary Agency has targeted 40 older generic chemotherapeutics for revised labeling; FDA will develop the new labeling, which will include currently accepted uses, but needs the cooperation of reference product holders who would actually have to submit the supplement. The US FDA is embarking on a mission to update labeling of generic chemotherapy…
Executive Summary When is a two-week review not a two-week review? When it is part of the US FDA’s Oncology Center of Excellence “real-time review” pilot program. The “left shifted” review pilot is off to a good start, but it may be time to rethink the concept of FDA review clocks. Novartis AG, Amgen Inc.,…
Executive Summary Pilot program that gives agency early look at pivotal data has forced sponsors to change how they go about preparing supplemental applications; potential expansion to new molecular entities would bring new challenges, including need to align manufacturing and clinical site inspections with expedited review timeline. The US FDA’s Real-Time Oncology Review (RTOR)…
Executive Summary Pilot project allows FDA conclusions about a drug’s efficacy and safety to be integrated with, but distinguished from, a sponsor’s own analysis; though currently used for reviews of oncology applications, template could become the basis for a consolidated advisory committee briefing document. The US FDA’s Assessment Aid (AAid) pilot project resulted from…
