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Home
  • About
      1. Board of Directors
      2. Our Staff
      3. Annual Reports
      4. Policies
      5. Fellowship
      6. Careers
  • Projects
      1. Column 1
        1. Animal Health & Veterinary Medicine
          1. Antimicrobial Use in Food Animals
          2. Industry SWOT Analysis
        2. Expanded Access
          1. E-request App
          2. Navigator
          3. Resources for COVID-19
        3. FDA Patient Listening Sessions
        4. Food & Nutrition
          1. About
          2. Food Traceability
          3. Healthy Rule Roundtables
          4. Nutrition Facts Label
          5. Produce Safety Stakeholder Dialogue
          6. Retail Dietitian Toolkit
      2. Column 2
        1. Improving Access to FDA Information
          1. Understanding FDA & FDA-Regulated Products
          2. Improving Access to Publicly Available FDA Information
        2. Research
          1. About
          2. Cross-Sectoral Health Threats
          3. IMEDS
          4. Post Market Research
          5. RAISE
          6. Real World Data
          7. Regulatory Science Accelerator
        3. Substance Use Disorders
  • News and Events
      1. Innovations in Regulatory Science & Policy Awards
      2. 2024 Annual Public Meeting
      3. Events
      4. News
      5. Publications
  • Expanded Access eRequest

What is Narcan? The opioid overdose spray, explained. - Vox

A long-sought tool in the fight against America’s opioid crisis is becoming available later this year: Narcan, the nasal spray that can stop opioid overdoses as they are happening, will finally be sold over the counter.

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Coverage
  • Read more about What is Narcan? The opioid overdose spray, explained. - Vox

FDA Approves Opioid Overdose Treatment Narcan for Over-the-Counter Sales - Rolling Stone

AN OVER-THE-COUNTER NASAL spray version of Narcan, the medication used to reverse the effects of an opioid overdose, was officially approved by the Food and Drug Administration today, March 29. 

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Coverage
  • Read more about FDA Approves Opioid Overdose Treatment Narcan for Over-the-Counter Sales - Rolling Stone

Drug overdose antidote Narcan goes over-the-counter - The Washington Post

Narcan, the lifesaving nasal spray that reverses opioid overdoses, has been approved for purchase without a prescription, the Food and Drug Administration announced on Wednesday.

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Coverage
  • Read more about Drug overdose antidote Narcan goes over-the-counter - The Washington Post

Over-the-Counter Narcan Could Save More Lives. But Price and Stigma Are Obstacles. - New York Times

If Narcan, the nasal spray that saves lives by reversing opioid overdoses, receives approval to be sold over the counter, public health officials hope the palm-size plunger could one day become as commonplace as a kitchen fire extinguisher.

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Coverage
  • Read more about Over-the-Counter Narcan Could Save More Lives. But Price and Stigma Are Obstacles. - New York Times

Biden officials flood the Hill - POLITICO

FDA ON THE HILL: Califf on Wednesday will testify before the House Appropriations Committee on Biden’s fiscal 2024 budget.

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Coverage
  • Read more about Biden officials flood the Hill - POLITICO

Generating evidence for racial and ethnic minorities during development of oncologic therapeutics - Regulatory Focus

Discussions regarding diversity, equity, and inclusion in healthcare and clinical research have been ongoing for decades. However, the COVID-19 global pandemic brought about a new focus on this issue.

Coverage
  • Read more about Generating evidence for racial and ethnic minorities during development of oncologic therapeutics - Regulatory Focus

Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force - LexBlog

There is a common refrain that appears throughout the Reagan-Udall Foundation report on the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA) — lack of transparency.

Coverage
  • Read more about Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force - LexBlog

Even over the counter, Narcan may be too costly to reach many drug users - Washington Post

Before month’s end, federal regulators are poised to allow over-the-counter sale of a nasal spray that reverses the potentially lethal effects of an opioid overdose. But groups that work to reduce the toll of drugs on the streets have one question: Will anybody be able to afford it?
Coverage
  • Read more about Even over the counter, Narcan may be too costly to reach many drug users - Washington Post

Coalition wants an audience with the Senate committee to discuss FDA leadership - LexBlog

A coalition of consumer and industry groups is seeking a meeting with a Senate committee regarding the head of the FDA and his response to a recent report calling for a reorganization of the agency.
Coverage
  • Read more about Coalition wants an audience with the Senate committee to discuss FDA leadership - LexBlog

The FDA’s CTP Review Uncovers Multiple Issues - The Vaping Post

It is no secret that the FDA has been under scrutiny for multiple reasons related to the authorization of safer nicotine alternative products. Last Summer the agency was heavily criticised by Senators Dick Durbin (D-Ill.) and Susan Collins (R-Maine). 

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Coverage
  • Read more about The FDA’s CTP Review Uncovers Multiple Issues - The Vaping Post

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© Reagan-Udall Foundation for the FDA
© Reagan-Udall Foundation for the FDA