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Category > Biology Posted 19 Dec 2017 My Price 13.00

Assignment 1 due week FDA Meetings

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Northeastern UniversityJ. Jennings, InstructorRGA 6220 Summer Term 2017Assignment 1 instructionsAssignment 1 due Week 7 FDA MeetingsDuring biologic development there are opportunities to meet withvarious regulators to discuss the product and the development programfor the product.This assignment will focus on US and FDA feedback.FDA has a number of guidances regarding meetings that sponsors canrequest in order to start dialogue regarding their biologic productdevelopment program.Biologic development doesn’t necessarily followthe same path as small molecule development therefore it is always agood idea to solicit feedback from FDA.FDA meetings are free and thefeedback can be invaluable.I want you to pick a biologic product and write a meeting request toFDA.Use the following:Guidance for Industry, Formal Meetings Between the FDA andSponsors or Applicants, Revision 1, dated May 2009.www.fda.govYou are going to request either a Type B or Type C meeting.I want youto have a minimum of three questions covering preclinical, clinical, andpediatric testing.The meeting request including the cover letter shouldbe a minimum of 5 pages. You will follow the template that is providedin the guidance document. We will go over preclinical and clinical inWeek 4.I am providing this information on the assignment now so that you canchoose a biologic product and start researching it now.Remember thatin the real world FDA will not know anything about your product.Providing a detailed succinct background section on your product iscritical.Post any questions in the Discussion Board “Ask the Instructor” thread.
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Status NEW Posted 19 Dec 2017 07:12 AM My Price 13.00

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