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New FDA Draft Guidance: Extended Expiration Dating for Doxycycline
The Food and Drug Administration (FDA) recently published new draft guidance, titled: “Extending Expiration Dates of Doxycycline...
May 08, 2017 | Raymond Puerini
FDA Medical Device Ban: Powdered Gloves
The Food and Drug Administration (FDA) published a final rule banning powdered gloves due to the unreasonable and substantial risk of...
Jan 25, 2017 | Anastasia Sonneman
UPMC Releases Casebook for Ensuring MCM Stewardship in an Emergency
In November 2016, the UPMC Center for Health Security released a new communication casebook, entitled How to Steward Medical...
Dec 13, 2016 | Raymond Puerini
Emerging MCM Practices Revealed at the ASPR Regional Summits
By Raymond Purerini, NACCHO Senior Program Analyst Throughout the month of August the Office of the Assistant Secretary for...
Oct 14, 2016 | Anastasia Sonneman
FDA to Host Competition to Develop Naloxone Mobile App
The U.S. Food & Drug Administration (FDA) is hosting the 2016 FDA Naloxone App Competition (#naloxoneapp) to encourage computer...
Sep 26, 2016 | Kim Rodgers
FDA: Final Environmental Assessment for Genetically Engineered Mosquito
Recently, the US Food and Drug Administration (FDA) conducted an environmental review to determine the potential effect of genetically...
Aug 12, 2016 | Anastasia Sonneman
New Emergency Use Instructions Available for Doxycycline and Ciprofloxacin
Jul 06, 2016 | Raymond Puerini
FDA Extends Expiration Dates of Certain Lots of State and Local Held Doxycycline
The Food and Drug Administration (FDA) has recently released a memo indicating that six lots of Doxycycline Hyclate 100-mg tablets...
Jun 03, 2016 | Raymond Puerini
Draft Emergency Use Authorization Guidance Available for Public Health Stakeholder...
The Food and Drug Administration (FDA) recently published updated draft guidance entitled ‘‘Emergency Use Authorization of Medical...
May 04, 2016 | Raymond Puerini
New FDA Draft Guidance: Extended Expiration Dating for DoxycyclineThe Food and Drug Administration (FDA) recently published new draft guidance, titled: “Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles; Draft Guidance for Government Public Health and Emergency Response Stakeholders.” The draft guidance is also published in the Federal Register and electronic and written comments are currently being accepted until June 26,... May 08, 2017 | Raymond Puerini |
FDA Medical Device Ban: Powdered GlovesThe Food and Drug Administration (FDA) published a final rule banning powdered gloves due to the unreasonable and substantial risk of illness or injury to individuals exposed to powdered gloves. Effective January 18, 2017, the medical device ban includes powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeon’s gloves. This ban […] Jan 25, 2017 | Anastasia Sonneman |
UPMC Releases Casebook for Ensuring MCM Stewardship in an EmergencyIn November 2016, the UPMC Center for Health Security released a new communication casebook, entitled How to Steward Medical Countermeasures and Public Trust in an Emergency: A Communication Casebook for FDA and Its Public Health Partners. The purpose of this resource is to assist the Food and Drug Administration (FDA) and other public health officials in ensuring […] Dec 13, 2016 | Raymond Puerini |
Emerging MCM Practices Revealed at the ASPR Regional SummitsBy Raymond Purerini, NACCHO Senior Program Analyst Throughout the month of August the Office of the Assistant Secretary for Preparedness and Response (ASPR) hosted six regional medical countermeasure (MCM) summits across different regions of the nation including San Diego, CA, Providence, RI, Washington, DC, Salt Lake City, UT, Oklahoma City, OK, and Kansas City, MO. […] Oct 14, 2016 | Anastasia Sonneman |
FDA to Host Competition to Develop Naloxone Mobile AppThe U.S. Food & Drug Administration (FDA) is hosting the 2016 FDA Naloxone App Competition (#naloxoneapp) to encourage computer programmers, public health advocates, clinical researchers, entrepreneurs and innovators from all disciplines to develop creative strategies to combat the rising epidemic of opioid overdose. Specifically, the goal of this competition is to spur innovation around the... Sep 26, 2016 | Kim Rodgers |
FDA: Final Environmental Assessment for Genetically Engineered MosquitoRecently, the US Food and Drug Administration (FDA) conducted an environmental review to determine the potential effect of genetically engineered (GE) mosquitoes (OX513A), developed by Oxitec Ltd., on the Aedes aegypti mosquito, one of the most commonly known carriers of the Zika Virus. The review assessed a proposed field trial to release the GE mosquitoes […] Aug 12, 2016 | Anastasia Sonneman |
New Emergency Use Instructions Available for Doxycycline and CiprofloxacinJul 06, 2016 | Raymond Puerini |
FDA Extends Expiration Dates of Certain Lots of State and Local Held DoxycyclineThe Food and Drug Administration (FDA) has recently released a memo indicating that six lots of Doxycycline Hyclate 100-mg tablets manufactured by West-Ward Pharmaceuticals may be used beyond their labeled expiration dates assuming they were stored under the manufacturer’s labeled storage conditions. FDA is not requiring that these products be relabeled but stakeholders who dispense these... Jun 03, 2016 | Raymond Puerini |
Draft Emergency Use Authorization Guidance Available for Public Health Stakeholder CommentThe Food and Drug Administration (FDA) recently published updated draft guidance entitled ‘‘Emergency Use Authorization of Medical Products and Related Authorities’’ for public health stakeholder and industry comment. This is an update to the July 2007 Emergency Use Authorization (EUA) guidance to reflect Pandemic and All-Hazards Preparedness Re-authorization Act (PAHPRA) amendments to the EUA... May 04, 2016 | Raymond Puerini |
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