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Role of FDA in Guiding Drug Development;?;Guiding Drug DevelopmentWhy FDA?;When does FDA get involved ?;FDA Initiative: Innovation vs Stagnation - Challenge Opportunity on the Critical Path to New Medical Products, March 2004;How does FDA guide drug development?;What comprises FDA guidance ?;How Many Guidancesand are they Binding ?;Planned Guidances (as of 2000);EXAMPLE 1Clinical/Pharmacological Guidances;EXAMPLE 2Clinical/Pharmacological Guidances;EXAMPLE 3Clinical/Medical Guidances;EXAMPLE 4Statutory Guidance: FDA Modernization Act of 1997“FDAMA”;FDAMA, Sec. 111 Pediatric studies of drugs;Pediatric Labeling Regulations(21 CFR 201.56);FDAMA, Sec. 115a Clinical investigations;FDAMA, Sec. 115aClinical investigations CONGRESSIONAL COMMITTEE REPORTS1 ;New Formulations and Doses of Already Approved Drugs*;;FDA – what’s new?;McClellan Initiative (2003): FDA leadership to improve drug development;“Academics” Meeting April 5, 2003;How can academics help?;‘Academics to CDER’;;;New Drug Applications;Innovation;Coordinate collaborative efforts among government, academia, industry patient groups Encourage “toolkits” for better product development, safety, medical utility manufacturing Build support for academic science bases in relevant disciplines Build opportunities to share existing knowledge databases Develop enabling standards;Organization of Critical Path Initiative within FDA;/oc/initiatives/criticalpath/;;Executive Summary Six Priority Public Health Challenges;;;;;/oc/initiatives/criticalpath/opportunities06.html;Critical Path Collaborations with NIH;Public/Private Partnerships - I;“American Course on Drug Development and Regulatory Science” Website: ;“ACDRS” Vision and Mission;“ACDRS” Emphases ;“ACDRS” Faculty and Teaching Methods;The Launch ;Critical Path Initiative Projectsthat impact Exploratory Clinical Development - two examples;;Goals of the Exploratory IND;Exploratory IND;Types of Exploratory Studies;Requirements;;;End of Phase 2a