An official website of the United States government Here’s how you know The .gov means it’s official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any …
On this page: Selected Participants What Happens Next? Background on the Challenge Criteria for Challenge Application Review Resources The opioid epidemic is one of the most profound public health crises facing the United States and the current crisis of opioid overdose deaths requires innovative approaches. The agency has already taken significant steps to decrease public …
FDA Innovation Challenge: Devices to Prevent Treat Opioid Use Disorder Read More »
The FDA is encouraging the development of prescription opioids with abuse-deterrent formulations (ADFs) to help combat the opioid crisis. The agency recognizes that abuse-deterrent opioids are not abuse- or addiction-proof but are a step toward products that may help reduce abuse. The FDA fully supports efforts to better understand the impact of these products in …
Meeting Information On July 9, 2018, FDA is hosting a public meeting on Patient-Focused Drug Development for Chronic Pain. FDA is interested in hearing patients’ perspectives on chronic pain, views on treatment approaches, and challenges or barriers to accessing treatments for chronic pain. FDA is particularly interested in hearing from patients who experience chronic pain …
Public Meeting on Patient-Focused Drug Development for Chronic Pain Read More »
On May 23, 2017, the Food and Drug Administration (FDA) Opioid Policy Steering Committee (OPSC) was established to explore and develop additional approaches or strategies FDA can use to combat the opioid crisis. The Committee is comprised of senior FDA leaders as designated by the Commissioner and resides in the Office of Medical Products and …
Extended-release, long-acting (ER/LA), and immediate-release (IR) opioid analgesics, such as hydrocodone, oxycodone, and morphine, are powerful pain-reducing medications that have both benefits as well as potentially serious risks. The FDA has determined that a REMS is necessary for all opioid analgesics intended for outpatient use to ensure that the benefits of these drugs continue to …
Risk Evaluation and Mitigation Strategy (REMS) for Opioid Analgesics Read More »
en Español Video: How to Dispose of Medicine Drug disposal options to consider and instructions for getting rid of old, expired, unwanted, or unused medicines Get Transcript How to Safely Dispose of Unused or Expired Medicine The best way to dispose of most types* of old, unused, unwanted, or expired medicines (both prescription and over …
Disposal of Unused Medicines: What You Should Know Read More »
Medication-assisted treatment (MAT) is the use of medications in combination with counseling and behavioral therapies, which is effective in the treatment of opioid use disorders (OUD) and can help some people to sustain recovery. More must be done to facilitate treatment options and the development of therapies to address OUD as a chronic disease with …
Integrated Food Safety System (IFSS) Read more about Programs and initiatives that advance the national Integrated Food Safety System (IFSS). IFSS Programs & Initiatives IFSS Programs & Initiatives Programs and initiatives that advance the national Integrated Food Safety System (IFSS). Funding Opportunities Information on grants, cooperative agreements, and contract programs for state, local, tribal, and …
For Federal, State, Local, Tribal, and Territorial Officials Read More »
An official website of the United States government Here’s how you know The .gov means it’s official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any …