BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:471958
DTSTAMP:20260411T083344Z
SUMMARY:ANDA Submission and GDUFA Guidance
DESCRIPTION:An ANDA is an Abbreviated New Drug Application. This appli
 cation is submitted to the FDA to seek approval to produce a U.S. gene
 ric drug from an existing patented approved drug. The ANDA is submitte
 d to FDA's Center for Drug Evaluation and Research, Office of Generic 
 Drugs. After approval, the applicant is able to produce and market the
  generic drug product.\n\nWhy Should You Attend:\nAnyone participating
  with the submittal process must understand how the process is structu
 red and operated in order to bring generic pharmaceuticals and therape
 utic products to market properly, successfully, and expeditiously. Fur
 thermore, with the passing of GUFDA II, which drastically alters the f
 ee structure, it is critical to comprehend the program's fundamental c
 hanges as well as their implications for the generics market.\n\nAreas
  Covered in the Webinar:\n\nOverview of the ANDA and PAS processes\nOv
 erview of GDUFA\nThe FDA’s process for classifying major, minor, and
  unsolicited amendments to ANDAs or PASs.\nHow ANDA or PAS deficiencie
 s that will cause the FDA to request a major amendment or classify def
 iciency responses as a major amendment.\nThe amendment format and subm
 ission process.\nThe FDA's review goals for amendments under GDUFA II.
 \nHow the FDA will process amendments submitted before GDUFA II.\n\nWh
 o Will Benefit:\nThe audience for this webinar would consist of anyone
  in the generic pharma business in the following functions:\n\nComplia
 nce and regulatory,\nResearch & development,\nQuality assurance.\nPosi
 tions would include – Director,\nAssociate Director,\nManager\nAssoc
 iates\n\n\nFor more information visit https://medtechiq.ning.com/event
 s/anda-submission-and-gdufa-guidance
DTSTART;TZID=America/New_York:20220328T100000
DTEND;TZID=America/New_York:20220328T130000
CATEGORIES:webinar
LOCATION:online
WEBSITE:https://www.complianceonline.com/anda-submission-gdufa-guidanc
 e-webinar-training-706791-prdw?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/anda-submission-gdufa-guidance-we
 binar-training-706791-prdw?channel=MedTech%20I.Q
CONTACT:8887172436
ORGANIZER:Complianceonline
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/10211562868?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
END:VEVENT
END:VCALENDAR