As promised, FDA released three new guidance documents specifically intended to help cancer drug development. These guidance documents cover common areas of concern in cancer clinical trials such as inclusion of older patients, concurrent recruitment of multiple cohorts to test the drug in multiple presentations of cancer in the same trial, and master protocols. These … Read more
A group of Republican Congressmen wrote to FDA last month raising concerns about LDTs for prenatal genetic testing and as expected, FDA wrote back asking them to pass laws to regulate LDTs. FDA’s answer is a repeat of what it has said for the last decade or more, that it wants to regulate these diagnostic … Read more
The first company to get FDA approval for an app with medical claims, Akili, had miserable sales of only $377,000 over almost a year with its product. The company’s projection of $500M+ revenue per year seems outlandish in the face of that. Whether it is a financial success or a bust, Akili could become the … Read more
FDA is strongly pushed back on attempts by a Chinese company seeking approval for a new cancer drug based on clinical data from one Phase 3 study conducted in its entirety in China. While this decision may seem contrary to earlier statements by FDA leaders that were interpreted to mean that FDA would accept pivotal … Read more
In response to a report from the GAO chastising FDA for its inadequate foreign audit practices particularly in India and China, FDA promised to start unannounced inspections at manufacturing plants in India and China in “early 2022”. FDA also promised to actively hire more inspectors able to travel to India and China by offering higher … Read more
Remote care has arrived, thanks for the pandemic. For clinical trials also virtual or remote trials have become a necessity with all trials switching to remote trial management and operations to an extent unfathomable just two years ago. So, why do we even need to go back to the old 2019 methods? Perhaps this is … Read more
Compounding essential drugs at low cost is not a new idea but branding them as generic drugs is risky. Celebrity billionaire Mark Cuban announced a new generic drugs company that pledges to manufacture and sell prescription generic drugs at lower costs however the company will initially start a compounding pharmacy and then later convert to … Read more
The experiences and perspectives of patients and their caregivers could be invaluable in the design of clinical trials intended to evaluate a new product for them. However, the FDA expectations from the process used to involve patients in clinical trial design may create challenges for the sponsors and patients alike. In a new guidance document … Read more
FDA has increasingly relied on remote inspections of manufacturing facilities since March 2020. It announced resumption of the normal on-site inspections a few times since then and then re-paused on-site inspections due to the pandemic. Earlier this year, FDA had announced a similar pause in on-site inspections due to the spread of the omicron strain … Read more
Several 3D printed devices may be printed at the clinic rather than printed at a traditional manufacturing facility and shipped. But 3D printing operations still need to comply with FDA’s QSR and GMP requirements. FDA released a Discussion Paper listing three scenarios for 3D printed devices with examples and tips for complying with FDA’s requirements … Read more
