What’s the Rush?
“The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices.” It’s right there in their job description.
But with the release of new policies meant to promote innovation for patients with unmet clinical needs, the FDA is asking the American people to “accept some level of uncertainty” when it comes to a handful of gene therapies that have been fast-tracked through the approval process. (more…)