FDA Releases Guidance on Opioids - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Releases Guidance on Opioids


ePT--the Electronic Newsletter of Pharmaceutical Technology

In their effort to help industry develop abuse-deterrent opioids, FDA has released Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling, Draft Guidance (CDER, Silver Spring, MD, January 2013). This document gives guidance on studies conducted to demonstrate that a given formulation has abuse-deterrent properties, how FDA will evaluate the studies, and what labeling FDA will approve. The draft guidance fulfills mandates under the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Office of National Drug Control Policy’s (ONDCP) Prescription Drug Abuse Prevention Plan.

“The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation. This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse,” said FDA Commissioner Margaret A. Hamburg, MD, in a press release.

FDA will accept public comments on the draft guidance for 60 days and FDA “encourages additional scientific and clinical research that will advance the development and assessment of abuse-deterrent technologies.”  In addition, FDA will hold a public meeting to discuss feedback on the draft guidance.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here