Tag: 21st Century Cures Act
Medical science policy in the U.S. under Donald Trump
The election of Donald Trump was unexpected. Given Trump's history of antivaccine beliefs and conspiracy theories, coupled with a fervor for deregulation (a fervor shared by the Republican Congress), it is reasonable to fear what will happen to medical science policy during the next four years.
Forget stem cell tourism: Stem cell clinics in the US are plentiful
It's generally thought that quack stem cell clinics are primarily a problem overseas because the FDA would. never allow them on US soil. As a new survey shows, that assumption couldn't be more wrong.
“Precision medicine”: Hope, hype, or both?
I am fortunate to have become a physician in a time of great scientific progress. Back when I was in college and medical school, the thought that we would one day be able to sequence the human genome (and now sequence hundreds of cancer genomes), to measure the expression of every gene in the genome simultaneously on a single “gene chip,” and...
The 21st Century Cures Act: The (Somewhat) Good, The (Mostly) Bad, and The (Very) Ugly
The approval of new drugs and medical devices is a process fraught with scientific, political, and ethical landmines. Inherent in any such process is an unavoidable conflict between rigorous science and safety on the one side, which tend to slow the process down by requiring large randomized clinical trials that can take years, versus forces that demand faster approval. For example, patients...