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UID:2140535:Event:68877
DTSTAMP:20260519T122143Z
SUMMARY:Webinar on FDA Expectations from 505(b)(2) Product Development
  Pathway
DESCRIPTION:Description :\nA 505(b)(2) product is an improved or alter
 ed version or a new use application for a previously FDA-approved drug
 . This unique regulatory pathway, available only for marketing approva
 l in the US, offers an attractive pathway to cheaper and faster new dr
 ug development, particularly to a manufacturer with experience in deve
 loping generic products. It involves making significant changes to an 
 existing FDA approved product, called reference product, to create a n
 ew product with its own indication, formulation, population, and/ or o
 ther differences that need to be supported with clinical studies. A ma
 jor advantage of this pathway is that it allows a sponsor to rely, at 
 least in part, on the FDA’s findings of safety and/or effectiveness 
 for a previously approved drug, thereby reducing the number of clinica
 l trials required for approval. The biggest incentive to develop 505(b
 )(2) products is 3 years of market exclusivity available to the approv
 ed product.\nThis seminar will discuss the practical strategies for dr
 ug development via 505(b)(2) regulatory pathway. Key strategic conside
 rations will be discussed using real-life case studies. Also discussed
  will be role of interactions with the FDA, global clinical trials, ma
 rket access, reimbursement issues and projected trends for the near fu
 ture. Lastly, the 505(b)(2) pathway will be compared to that for biosi
 milars.\nAreas Covered in the Session :\nThe 505(B)(2) regulation and 
 guidance from the FDA\nStrategic considerations before embarking on a 
 505(b)(2) development project\nIntellectual property issues with such 
 products\nKey development steps for such products\nFDA’s review proc
 ess and ongoing consultation\nChallenges to developing 505(b)(2) produ
 ct and possible solutions\nExamples of successful strategies for devel
 oping such products\nSearching for a 505(b)(2) project, future trends\
 n505(b)(2) and biosimilars\nSpeaker's PASS-IT Recommendations\nWho Wil
 l Benefit:\nCEOs\nVPs\nCompliance Officers\nAttorneys\nRegulatory Affa
 irs\nClinical Affairs\nQuality Assurance\nResearch & Development\nProj
 ect Managers\nConsultants\nContractors/Subcontractors\n\nFor more info
 rmation visit https://medtechiq.ning.com/events/webinar-on-fda-expecta
 tions-from-505-b-2-product-development
DTSTART;TZID=America/New_York:20160412T130000
DTEND;TZID=America/New_York:20160412T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1784
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1784
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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