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Emer Cooke, executive director of EMA, is encouraged by the competitiveness of the European pharmaceutical market.

Innovation, Collaboration, and Performance Were Highlights for EMA in 2024

The company is voluntarily recalling all lots of Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP) 30 mg/30 mL (1 mg/mL) 30 mL vials due to misleading labeling and its status as an unapproved drug. 

Endo Recalls Adrenalin Chloride Solution 

A pilot program to explore creation and testing of ePIs in regulatory procedures shows positive results.

Electronic Product Information Moves Forward in Europe

EMA recommended 17 drugs for marketing authorization in December, including treatments for rare heart conditions, anemia, and liver disease.

Several Orphan Drugs Among Medicines Recommended for Approval by EMA in December

The Center for Drug Evaluation and Research’s new center will coordinate and promote use of real-word data in regulatory decisions.

FDA Creates CDER Center for Real-World Evidence Innovation 

The first CPHI Middle East event will be held Dec. 10–12, 2024 at the Riyadh Front Exhibition & Convention Center Riyadh in Saudi Arabia and is expected to be host to 30,000 pharma professionals.

CPHI Middle East Sees Domestic Manufacturing Expansion in Saudi Arabia

The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.

FDA Releases Guidance on Accelerated Approvals

The agency’s safety committee found no sufficient evidence of causal relationship between the antibiotic doxycycline and the risk of suicide or suicidal thoughts.

No Causal Link Between Doxycycline and Suicide, Says EMA Safety Committee 

A new platform allowing market authorization holders to report drug shortages has gone live. 

EMA Announces Drug Monitoring Platform

Mike Hennessy Jr. is the President and CEO of 

The 340B program is under greater scrutiny with more transparency for drug access being demanded by industry.

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