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Orange Book Exclusivity: Part II - Pediatric, Orphan, and GAIN 

U.S. Food and Drug Administration
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FDA provides information on pediatric, Generating Antibiotic Incentives Now (GAIN), orphan exclusivities and impacts on ANDAs and 505(b)(2)s.
FDA Presenters
Kristiana Brugger Division of Regulatory Policy IV (DRPIV) Office of Regulatory Policy (ORP) | CDER
Aaron Friedman Office of Orphan Products Development (OOPD) Office of Clinical Policy and Programs (OCPP) Office of the Commissioner (OC)
Katherine Schumann Division of Regulatory Policy (DRP) Office of New Drug Policy (ONDP) OND | CDER
Learn more at www.fda.gov/dr...
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  
 
Upcoming Training - www.fda.gov/cd...
SBIA Listserv - public.govdeli...
SBIA 2020 Playlist - www.youtube.co...
SBIA LinkedIn - / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cd...
Twitter - / fda_drug_info  
Email - CDERSBIA@fda.hhs.gov  
Phone - (301) 796-6707 I (866) 405-5367

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4 окт 2024

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