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UCSF-CDDS 2007 Role of FDA in Guiding Drug Development Carl Peck Center for Drug Development Science UCSF, UC-Washington Center Washington DC ? Why FDA ? When does FDA get involved ? How does FDA guide drug development? What comprises FDA guidance ? What’s new at FDA ? Guiding Drug DevelopmentWhy FDA? FD&C Act: history and its supporters resulted from public safety events or public health challenges ~ 1902/6, 1938, 1962, 1972, 1987, 1997, 2004 a uniquely American phenomenon Evolution of Drug Regulation (R. Temple) When does FDA get involved ? Preclinical (voluntary) phase animal testing Pre-IND guidance: Subpart E, Fast Track, Orphan designations Clinical development phase IND NDA review Marketing phase ADR surveillance new uses, product changes, withdrawals How does FDA guide drug development? Written guidances Regulations, guidelines (incl. ICH), guidances1 Regulatory letters (Statute, Congressional Reports) Face-to-face meetings Pre-IND, EOP2a, EOP2, as-needed FDA Advisory Committee meetings Podium presentations What comprises FDA guidance ? Standards chemistry and manufacturing controls (CMC) preclinical animal toxicology requirements ethics of human clinical trials documentary requirements for INDs, & NDAs Electronic records (21 CFR part 11) Clinical trials safety effectiveness trial design How Many Guidancesand are they Binding ? GUIDANCES (/cder/guidance.htm) 344 guidances (final/draft, FDA/ICH), 3/31/00 Guidance documents: Cannot legally bind FDA or the public Recognizes value of consistency & predictability Because a company wants assurance So staff will apply statute & regulations consistently Planned Guidances (as of 2000) EXAMPLE 1Clinical/Pharmacological Guidances CDER Comprehensive List of Guidance Documents (April 2006; n ~ 500) Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro (97); In Vivo (99) Pharmacokinetics in Patients with Impaired Renal Function (98) Population Pharmacokinetics ( 9