The guidances issued today by the FDA are part of a larger initiative by the administration to increase patient access to high-quality generics.
On the heels of a massive EpiPen shortage, the U.S. Food and Drug Administration has approved the first generic alternative.
Use of FDA-approved nicotine replacement therapy products may double the likelihood of a successful attempt to quit smoking.
The task force is charged with identifying the reasons why some shortages remain a persistent challenge and to look for holistic solutions to addressing the underlying causes for these shortages.
The FDA established the Patient Engagement Advisory Committee in a move to broaden patient engagement and strengthen patients’ voice in regulatory activities.
The FDA is changing the way it approves medicines known as “orphan drugs” after revelations that drugmakers may be abusing a law intended to help patients with rare diseases.
The FDA can’t regulate drug prices, but it can implement measures aimed at deterring the types of price hikes that have made so many headlines over more than a year.
Researchers found nearly a third of approvals from 2001 through 2010 had major safety issues years after they were widely available to patients.