Regulatory requirements and product approvals for orphan drugs and combination products in US, EU and Canada

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Language: English Publication details: 2017Edition: 1Description: 137pSubject(s):

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Dissertation note: Venkatesh M PJSS UniversityP.Regulatory Affairs

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Holdings
Item type	Current library	Home library	Collection	Call number	Status	Barcode
Dissertation/Thesis	JSS College of Pharmacy, Mysuru	JSS College of Pharmacy, Mysuru	Pharmaceutics	615.48 DIV (Browse shelf(Opens below))	Available	D10441

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Previous	615.48 CHI Indian regulatory guidelines for conducting clinical trials	615.48 DHA Global scenario on pharmaceutical product recalls: regulatory perspective	615.48 DIV Comparison of regulatory requirements for registration of generics in BRICS countries	615.48 DIV Regulatory requirements and product approvals for orphan drugs and combination products in US, EU and Canada	615.48 DIV Registration requirement for generic drug in Thailand, Malaysia and Taiwan	615.48 ESH Comparison of marketing authorization and its requirements for ASEAN market and India	615.48 ESH Pharmaceutical regulations, organizational structure, requirements for pharmaceutical product registration and marketing authorization for UAE	Next