The FDA is encouraging drugmakers to conduct fewer clinical trials on certain proposed medication-assisted therapies for opioid use disorder, saying a streamlined approach will help patients access treatment quicker.
The FDA's approval process for medical devices has been criticized for years for failing to catch problems with defective implants.
The agency approved marketing a device that can detect diabetic retinopathy by analyzing images of the eye.
U.S. health officials are placing new restrictions on a permanent contraceptive implant that has been subject to reports of painful complications from thousands of women. But the metal implant called Essure will remain on the market.
The House on Wednesday passed a bill that would allow dying patients to receive experimental treatments. Here's how, if it passes, the bill would affect providers.
The CMS will now cover diagnostic laboratory tests using gene sequencing technology for Medicare cancer patients. The agency said the tests can help patients and their oncologists make better treatment decisions.
Congress failed to approve a measure that would provide another avenue for terminally ill patients to get access to experimental drugs.
The Food and Drug Administration has approved the first direct-to-consumer breast cancer gene test, but it will require 23andMe to warn consumers about the limitations of the genetic information.
As a healthcare executive long involved in supply-chain procurement for hospitals, I've been flooded with calls from hospital CEOs asking why so many of the pharmaceuticals they need to deliver care are so difficult to secure in sufficient quantities.
The test doesn't detect concussions and the approval won't immediately change how patients with suspected concussions are treated. But it allows Banyan Biomarkers to commercialize its test, giving the company an early lead in the race to find a way to diagnose concussions.
Pharmaceutical stocks dipped Thursday following the announcement that four large health systems will partner to create a not-for-profit generic drug company.
Combating the opioid crisis and promoting greater generic drug competition are among a set of the FDA's top policy priorities for 2018 the agency released this week.