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Clinical trials in the US lack demographic diversity. Multiple programs from FDA in the last 5-10 years to boost higher clinical trial participation from Black and Latino patients in the US have failed. However, recruiting patients from countries in Africa and South America has not been discussed much even though it may be one way … Read more

The US government shipped free home tests for Covid to every home in the US. The magnitude of this event should not be lost. It is the first time that home tests for any infectious disease got such a strong endorsement from the Federal government. Does this indicate that home tests for other infectious diseases … Read more

Even though the US government has not officially withdrawn the Declaration of Public Health Emergency (PHE) related to Covid from February 2020, there are multiple reports that FDA is not accepting any new Emergency Use Authorization (EUA) applications for diagnostic products under that Emergency. Typically, such rejections from the FDA come with a suggestion to … Read more

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