Expedited FDA Programs
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Descripción
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the...
mostra másTo expedite the evaluation of new drugs and review of marketing applications for drugs addressing unmet medical needs for patients with serious or life-threatening conditions, the FDA has established four expedited programs: Fast Track Designation, Breakthrough Therapy Designation, Priority Review, and Accelerated Approval. This episode examines FDA Expedited Programs with CDER’s Senior Regulatory Expedited Programs Manager, Miranda Raggio.
Información
Autor | ACT ToxChats |
Organización | ACT ToxChats |
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