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US FDA's Words Matter: Sharpless Says Injectable Naloxone OK For Community Distribution

 
• By Derrick Gingery

The acting commissioner's statement is intended to clarify "persistent misunderstanding" about the label for the opioid overdose rescue medication's injectable formulation.

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Community distribution programs like injectable naloxone, in part because it is the cheapest to purchase. • Source: Shutterstock

The US Food and Drug Administration is hoping a written statement, rather than a label change, will suffice as the necessary clarification that the injectable naloxone formulation is appropriate for community distribution.

Acting US Food and Drug Administration Commissioner Norman Sharpless addressed what he called "a persistent misunderstanding" that the label for...

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More from US FDA

Access Risks Loom For All Drugmakers With Fourth Circuit Mifepristone Decision

 
• By Sarah Karlin-Smith

The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.

US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming

 
• By Derrick Gingery, Sue Sutter, and Sarah Karlin-Smith

The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 
• By Sarah Karlin-Smith

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

More from Agency Leadership

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 
• By Sarah Karlin-Smith

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

Opuni Appointed Acting CEO Of Ghana’s FDA As Darko Leaves To Lead African Medicines Agency

 
• By Anabel Costa-Ferreira

Kwabena Frimpong-Manso Opuni has been appointed as the new acting CEO of the Ghana Food and Drugs Authority, succeeding Delese Darko, who is now head of the Africa’s pan-continental medicines agency.