SAMHSA – Substance Abuse and Mental Health Services Administration
The Substance Abuse and Mental Health Services Administration (SAMHSA) is the agency within the U.S. Department of Health and Human Services that leads public health efforts to advance the behavioral health of the nation. SAMHSA’s mission is to reduce the impact of substance abuse and mental illness on America’s communities.
NIH – National Institute of Health
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency — making important discoveries that improve health and save lives.
NIDA – National Institute of Drug Abuse
Submitted by NIDA on August 22, 2017 – While there is some abuse potential with Suboxone (buprenorphine-naloxone), it is less than other opioids, and research suggests those risks are outweighed by its great benefits in treating opioid use disorders. Data also suggest that most misuse is for controlling withdrawal and cravings, rather than obtaining euphoria. Research on the question of treatment need versus diversion risk for buprenorphine and methadone is summarized in our report Medications to Treat Opioid Addiction.
American Association for the Treatment of Opioid Dependence
The American Association for the Treatment of Opioid Dependence works with federal and state agency officials concerning opioid treatment policy throughout the United States. We also work with our partner, the World Federation for the Treatment of Opioid Dependence, with regard to international initiatives and working with designated agencies within the United Nations.
Helpful Links and Resources
- National Institute of Health – The Interagency Pain Research Coordinating Committee
The NIH established the Interagency Pain Research Coordinating Committee to coordinate all pain research efforts within HHS and across other Federal Agencies. The Committee is composed of seven Federal members and twelve non-Federal members, six drawn from the scientific and medical communities and six members of the public and stakeholder groups. The Department of Health and Human Services Secretary will review the necessity of the Committee at least once every 2 years
- FDA 505(B)(2) – Guidance for Industry “Applications Covered by Section 505(b)(2)
This document is from the FDA website. This is an excellent resource to learn almost everything you need to know about 505b2.
- National Academies of Sciences, Engineering, and Medicine report for the FDA titled “Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use”
- CDC Guideline for Prescribing Opioids for Chronic Pain
CDC developed and published the CDC Guideline for Prescribing Opioids for Chronic Pain to provide recommendations for the prescribing of opioid pain medication for patients 18 and older in primary care settings. Recommendations focus on the use of opioids in treating chronic pain (pain lasting longer than 3 months or past the time of normal tissue healing) outside of active cancer treatment, palliative care, and end-of-life care.
- Camargo 505(b)(2)
Camargo Pharmaceutical Services is the most experienced global strategist providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and analogous European processes. By assessing the scientific, medical, regulatory and commercial viability of product development opportunities, Camargo systematically builds and executes complete development plans that align with business strategies and that ensure FDA buy-in every step of the way. Routinely holding three to six pre-IND meetings a month, Camargo has guided more than 200 FDA approvals and works with product developers across more than 25 countries.
Bridge Therapeutics” and the Bridge Therapeutics logo, is a trademark of Bridge Therapeutics Inc. in the United States.
This site contains the trademarks and company names of third parties for identification purposes only. Trademarks and company names are the property of their respective owners.