WHO Proposes Regulatory Flexibilities For Testing MAbs Against Infectious Diseases
Executive Summary
A draft guideline from the World Health Organization intends to clarify regulatory expectations for the assessment of mAbs used for preventing and treating infectious diseases in health emergencies and to help with international harmonization efforts in this field.
You may also be interested in...
New COVID Treatments Face FDA, Commercial Barriers Despite Ongoing Need
Sponsors want more endpoint clarity as current state of government pandemic response, along with scientific and regulatory hurdles, is constraining efforts to refill a shrinking COVID medicine cabinet and could create vulnerabilities for future pandemics.
Post-Brexit UK Risks Being ‘Left Out In The Cold’ As EU Coordinates Action On Shortages
The UK is not alone in experiencing drug shortages, as data from across Europe show, but its departure from the EU makes it more difficult to respond to supply chain pressures, according to new research.
EU Countries Offered Funding To Contribute to African Regulatory Strengthening
Training projects are intended to strengthen the African regulatory environment, boost the capacity of the African Medicines Agency, facilitate regulatory reliance, and increase joint new drug assessments.