The agency notified 74 manufacturers of so-called immediate-release opioids that their drugs will now be subject to the tougher requirements, although doctors would not be compelled to take part in the training.
Rural hospitals have long wanted to be part of the so-called 340B program, too, but were blocked from participating until the Affordable Care Act . But, unlike bigger hospitals, rural hospitals can't get discounts on expensive drugs that treat rare diseases.
The FDA's approval of a new type of duodenoscope could help cut down on hospital-acquired infections, which have been a problem for the G.I.-focused device.
The Food and Drug Administration will host a meeting Monday to discuss changes to the approval process of new drugs. The agency is under immense pressure to speed up the approval of new drugs while also ensuring they are safe.
Gilead Sciences has a knack for putting itself at the center of the drug pricing debate, this time with its new non-Hodgkin Lyphoma treatment that will cost over $500,000.
Safety advocates and state health officials are formally calling on the Food and Drug Administration to ban high-dose opioid painkillers to prevent accidental overdose deaths among patients and people who abuse drugs.
Opening a new era in cancer care, the Food and Drug Administration approved the first treatment that genetically engineers patients' own blood cells into an army of assassins to seek and destroy childhood leukemia.
Consumers' angst over the ACA is dwarfed by their concerns over the cost of healthcare and soaring prescription drug prices specifically. Time to do something about it.
As policymakers and the drug and device industry look for new ways to bring treatments for life-threatening conditions to the market sooner, providers are concerned that expedited approvals could compromise patient care.
With its new Software Precertification Pilot Program, the FDA hopes to find a way to reduce the now significant burden on companies to get their software approved.
Invacare is finally free to build as many wheelchairs as it pleases. The U.S. Food and Drug Administration has given the company permission to ramp up manufacturing at its Elyria, Ohio, plant.
The Food and Drug Administration in June took steps to increase competition by posting a list of branded drugs that are not protected by patent and are not facing looming generic drug rivals. The agency will fast-track its review of generic drug applications.