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TIRF REMS Debate: Advisory Committee Chair Speaks Out

 
• By Michael McCaughan

University of Kentucky anesthesiologist Raeford Brown says problem with transmucosal fentanyl regulation isn’t the REMS – it's that the products are approved at all. 

Risk Dial

The problems with continued misuse of transmucosal immediate release fentanyl products is not with the US FDA’s Risk Evaluation & Mitigation Strategy – but rather with the availability of the products at all, one of the members of FDA’s Anesthetic & Analgesic Drugs Advisory Committee that reviewed the TIRF REMS says in an email to the Pink Sheet.

“After five years of assessing the positions of the Agency, past mistakes, and the current state I am certain that there was never an indication for this drug, and that it is one of the most dangerous of all of the opioid

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

 
• By Urtė Fultinavičiūtė

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

 
• By Neena Brizmohun

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.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

US FDA Asks Adcomm If Opioid Postmarketing Studies Are Relevant, Warrant Action

 
• By Sue Sutter

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HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

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Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
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