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Home » EMA Guidance Details Postmarket Studies Drugmakers May Be Asked to Perform

EMA Guidance Details Postmarket Studies Drugmakers May Be Asked to Perform

July 22, 2013
The European Medicines Agency June 17 issued updated guidance on postmarketing authorization measures, spelling out five types of postapproval studies the agency may specify during review of a marketing authorization application. The most serious category — a specific obligation — is reserved for marketing authorizations that are granted under exceptional circumstances or with special conditions.
International Pharmaceutical Regulatory Monitor

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