US FDA Wants Opioid Prescribing Guidelines To Be Highly Specific, But It May Have To Compromise

National Academies of Sciences, Engineering, and Medicine committee meeting suggest it is difficult to write condition-specific guidelines for opioid prescribing in the primary care setting.

Arrows miss target

The US FDA is hoping that the National Academies of Sciences, Engineering, and Medicine (NASEM) can help develop opioid prescribing guidelines that are highly specific, although experts cautioned there are some areas where guidelines may need to be more generalizable.

Speaking at a Feb. 4 meeting hosted by NASEM's Committee on Evidence-based Clinical Practice Guidelines for Prescribing Opioids for Acute Pain, Douglas Throckmorton, deputy center director for regulatory programs in...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Drug Safety

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By 

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By 

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

International Group Aims To Shape The Inevitable Future Of AI In Pharmacovigilance

 

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

More from Pink Sheet

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By 

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.