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New Opioid Approved by FDA, Mere Days After Trump Signs Opioid Bill
On October 24th, President Trump signed a package of bills designed to confront and combat the nation’s opioid epidemic. On November 2nd, the FDA approved Dsuvia.
New Drug to Treat the Flu Approved by FDA
The new drug, Xofluza, is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years.
New Guidances Issued to Promote Generic Drug Access and Drug Price Competition
The guidances issued today by the FDA are part of a larger initiative by the administration to increase patient access to high-quality generics.
First Generic EpiPen Approved by FDA
On the heels of a massive EpiPen shortage, the U.S. Food and Drug Administration has approved the first generic alternative.
FDA Supports New Steps to Further Nicotine Replacement Therapy Research
Use of FDA-approved nicotine replacement therapy products may double the likelihood of a successful attempt to quit smoking.
FDA Forms Drug Shortages Task Force
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.
FDA Involves Patient Perspectives in Regulatory Review Process
The FDA established the Patient Engagement Advisory Committee in a move to broaden patient engagement and strengthen patients’ voice in regulatory activities.
FDA Moves To Guard Against Abuse Of ‘Orphan Drug’ Program
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.
New FDA Commissioner Gottlieb Unveils Price-fighting Strategies
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.
As Trump Pressures FDA for Faster Drug Approvals, Major Safety Issues with Past Approvals Surface
Researchers found nearly a third of approvals from 2001 through 2010 had major safety issues years after they were widely available to patients.