Home » EMA Guidance Details Postmarket Studies Drugmakers May Be Asked to Perform
EMA Guidance Details Postmarket Studies Drugmakers May Be Asked to Perform
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
International Pharmaceutical Regulatory Monitor
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