FDA Exploring Naloxone Uptake and Use: Public Meeting and Request for Comments

The Food and Drug Administration (FDA) has posted information on a public meeting and a request for comments related to the uptake and use of Naloxone, a medicine used to reverse an opioid overdose. As announced in the Federal Register:

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, in collaboration with the National Institutes on Drug Abuse, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Health Resources and Services Administration, will hold a public meeting to discuss increasing the use of naloxone to reduce the incidence of opioid drug overdose fatalities. During the meeting, academic and government experts, industry representatives, and patient advocates will discuss which populations are at-risk for opioid drug overdose and how we can work together to encourage the use of naloxone to reduce the risk of overdose from opioid drugs.

Additional Details:

Date and Time: The public meeting will be held on July 1, 2015, from 8 a.m. to 5 p.m. and on July 2, 2015, from 8 a.m. to 3 p.m. The open public hearing will be held between 1 p.m. and 2 p.m. on July 1, 2015, and between 1 p.m. and 2 p.m. on July 2, 2015, during which speaker testimony will be accepted.

Location: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002.

Registration: If you wish to attend the public meeting or provide testimony during the open public hearing, please email your registration to NaloxoneWorkshop@fda.hhs.gov by June 22, 2015. Those without email access may register by contacting one of the contact persons (see Contact Persons). When registering, please provide complete contact information for each attendee, including name, title, affiliation, address, email address, and telephone number.

Comments: Submit either electronic or written comments by September 1, 2015. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For more information view the full announcement in the Federal Register.

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