FEATURED: FDA blog highlights the importance of collaboration to approve drugs

A U.S. Food and Drug Administration (FDA) blog posted April 10 highlights the benefits of FDA collaborations in reducing the number of unapproved drugs while working to prevent drug shortages. 

The blog was written by FDA Center for Drug Evaluation Associate Director of the Drug Shortage Staff Valerie Jensen and FDA Center for Drug Evaluation and Research Director of the Office of Compliance Cynthia Schnedar.

Many of the FDA’s recent drug approvals emphasize how different parts of the FDA work together to ensure a sufficient supply of FDA-approved drugs for U.S. consumers, the blog said. 

For example, the drug shortages team worked with the unapproved prescription drugs staff to obtain approval for formerly unapproved Bloxiverz, approved to reverse the effects of certain neuromuscular blocking agents after surgery, and Vasostrict, approved to increase blood pressure in adults in vasodilatory shock whose blood pressure remains low despite the administration of fluids and other efforts to raise it.

“Such approvals highlight the strength of collaborations between FDA’s shortages staff, our unapproved drugs team and the Office of New Drugs,” the blog said. “These approvals are crucial for FDA; once a drug is approved, we know what ingredients are in the drug, how it is made, and that it has been shown to be safe and effective for its labeled use.”