The US Food and Drug Administration's (FDA) recent proposal to overhaul the manner in which generic drug manufacturers may update the safety warnings on their labels may be receiving warm praise from ...
AbbVie ABBV announced that it has submitted a regulatory filing to the FDA seeking approval for a new indication of its ...
The FDA announced efforts to make clinical trials more efficient, starting by reviewing data in real time from trials ...
The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC) and prescription drugs. One of the ...
The FDA is requiring safety labeling changes to all opioid painkillers, to better highlight the risks posed by using the drugs long-term. The changes come after a public advisory committee meeting in ...
The Food and Drug Administration approved on Friday a label change for Pfizer's birth control shot Depo-Provera that warns patients of the risk of meningioma, a tumor in the lining of the brain.
The FDA may decide soon whether to ban using electric shocks on people with disabilities, including children with autism or ...
The US Food and Drug Administration (FDA) held a 2-day public hearing this week to solicit input about the marketing and use of medications and medical devices for off-label use. It is fairly common ...