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www.fdanews.com/articles/166617-anvisa-sets-criteria-scoring-mechanism-for-small-molecule-drug-priority-reviews

Anvisa Sets Criteria, Scoring Mechanism for Small Molecule Drug Priority Reviews

August 22, 2014

Brazil’s Anvisa issued a rule on June 18 establishing criteria for the priority review of small molecule drugs and biologics. Rule No. 37 applies to marketing authorization, postauthorization and clinical study applications.
International Pharmaceutical Regulatory Monitor