FDA’s latest regulatory agenda pulls LDT rule, spells out plans to issue a final rule on NDC
Regulatory NewsJoanne S. EglovitchApproval/marketing authorizationChemistry, Manufacturing and Controls (CMC)Clinical TrialsComplianceCompoundingGMPHealth Authority meeting and communication strategyMedical DevicesPediatric productsPharmaceuticalsPostmarketing requirement/postmarketing commitmentProduct developmentProposed ruleQuality Assurance and ControlRegulatory harmonizationUnited StatesUS Food and Drug Administration (FDA)
Regulatory NewsJoanne S. Eglovitch
Approval/marketing authorizationChemistry, Manufacturing and Controls (CMC)Clinical TrialsComplianceCompoundingGMPHealth Authority meeting and communication strategyMedical DevicesPediatric productsPharmaceuticalsPostmarketing requirement/postmarketing commitmentProduct developmentProposed ruleQuality Assurance and ControlRegulatory harmonizationUnited StatesUS Food and Drug Administration (FDA)