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UID:2140535:Event:67113
DTSTAMP:20260524T121728Z
SUMMARY:Webinar On Drug Master Files: New Implications under GDUFA
DESCRIPTION:Description :\nThe Generic Drug User Fee Amendments of 201
 2 (GDUFA) were designed to speed the delivery of safe and effective ge
 neric drugs to the public and reduce costs to industry. A Drug Master 
 File (DMF) is a submission to the Food and Drug Administration (FDA) t
 hat may be used to provide confidential detailed information about fac
 ilities, processes, or articles used in the manufacturing, processing,
  packaging, and storing of one or more human drugs. This webinar will 
 discuss the effect of GDUFA on the DMF process.\nGDUFA enables FDA to 
 assess user fees and bring greater predictability to the review of gen
 eric drug applications. The law requires industry to pay user fees to 
 supplement the costs of reviewing generic drug applications and inspec
 ting facilities. Additional resources enable FDA to reduce a current b
 acklog of pending applications, cut the average time required to revie
 w generic drug applications for safety, and increase risk-based inspec
 tions. It is important to have an understanding of GDUFA and the new f
 ees and requirements DMF holders must fulfill in order to achieve “A
 vailable for Reference” status. Only Abbreviated New Drug Applicatio
 n (ANDA) submissions with reference to “Available for Reference” A
 PI DMFs can be received by FDA. Not having clarity on the new fees and
  requirements could cost your organization time, money, and other crit
 ical resources.\nThis webinar will help you have a better understandin
 g of GDUFA, its implications regarding DMFs, who in industry is impact
 ed, the required fees, and achieving DMF “Available for Reference”
  status.\nAreas Covered in the Session :\nGeneric Drug User Fee Amendm
 ents: Background\nKey definitions\nWho in industry is impacted\nSelf-i
 dentification and fee requirements\nNew DMF correspondences and meetin
 gs\nCompleteness assessments\n“Available for Reference” status\nWh
 o Will Benefit:\nRegulatory Affairs Teams\nProject Managers\nQA & QC M
 anagers\nAPI manufacturers\nGeneric drug manufacturers\nType II (API) 
 DMF holders\nANDA Sponsors\nConsultants\nAny individuals interested in
  the generic drug industry\n\nFor more information visit https://medte
 chiq.ning.com/events/webinar-on-drug-master-files-new-implications-und
 er-gdufa
DTSTART;TZID=America/New_York:20151002T140000
DTEND;TZID=America/New_York:20151002T150000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1194
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1194
CONTACT:4169154458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
END:VEVENT
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