FDA CDER Small Business and
Industry Assistance (CDER SBIA)
March 27-28, 2014

Acronyms:

  ANDA = Abbreviated New Drug Application
API = Active Pharmaceutical Ingredient
DDI = Division of Drug Information
DMF = Drug Master File
eCTD = electronic Common Technical Document
GDUFA = Generic Drug User Fee Amendments
OBI = Office of Business Informatics
OC = Office of Compliance
OCOMM = Office of Communications
OGD = Office of Generic Drugs
OGD/DLPS = Office of Generic Drugs/Division of Labeling and Program
OM = Office of Management
OMPQ = Office of Manufacturing and Product Quality
ONDQA = Office of New Drug Quality Assessment
Day 1 - Thursday, March 27, 2014
GDUFA Overview
7:30a Registration Opens
8:20 - 8:30a Welcome
Brenda Stodart, Pharm.D
  Program Director
  CDER Small Business and Industry Assistance (CDER SBIA)
  Division of Drug Information (DDI)
  Office of Communications (OCOMM), CDER, FDA
8:30 - 8:45a Keynote Speaker
Kathleen Uhl, M.D. (remote)
  Acting Director
  Office of Generic Drugs (OGD), CDER, FDA
8:45 - 9:15a GDUFA Update: Accomplishments and Implementation (remote)  Abstract
Manju Thomas
  Operations Research Analyst
  Office of Strategic Programs, CDER, FDA
9:15 - 10:15a An Overview of the draft guidance for industry: ANDA Submissions--Refuse-to-Receive Standards (remote)  Abstract
Johnny Young, M.A.L.A.
  Regulatory Filing Reviewer
  Office of Generic Drugs/Division of Labeling and Program Support (OGD/DLPS), CDER, FDA
10:15 - 10:25a BREAK
10:25 - 12:00p A Filing Reviewer's Perspective on Electronically Submitted Documents  Abstract
Julia Lee, Pharm.D.
  Regulatory Filing Reviewer
  Office of Generic Drugs/Division of Labeling and Program Support (OGD/DLPS), CDER, FDA


Linh Vo, RPh. Abstract
  Regulatory Support Management Officer
  Regulatory Support Branch
  Office of Generic Drugs
  Food and Drug Administration


Optimizing your eCTD ANDA Abstract
Jared C. Lantzy, P.M.P.
  Operations Research Analyst
  CDER Office of Business Informatics (OBI), CDER, FDA
12:00 - 1:15p LUNCH ON YOUR OWN-Networking opportunity
1:15 - 2:00p Drug Master File (DMF) Basics  Abstract
Arthur Shaw, Ph.D.
  DMF Expert, Review Chemist
  Division of New Drug Quality Assessment III
  Office of New Drug Quality Assessment (ONDQA), CDER, FDA
2:00 - 2:10p BREAK
2:10 - 3:10p DMFs with a GDUFA perspective  Abstract
Huyi Zhang, Ph.D.
  Drug Master File (DMF) Review Staff
  Office of Generic Drugs (OGD), CDER, FDA


Completeness Assessment for Type II API DMF under GDUFA  Abstract
Wei Song, Ph.D.
  DMF Review Staff
  Office of Generic Drugs (OGD), CDER, FDA
3:10 - 3:45p
Q&A Panel of DMF experts
3:45p ADJOURNMENT
5:00 - 8:00p NETWORKING OPPORTUNITY (Pay on own) in John T's Bar Lounge located in the hotel lobby.



FDA CDER Small Business and
Industry Assistance (CDER SBIA)
March 27-28, 2014

Acronyms:

  ANDA = Abbreviated New Drug Application
API = Active Pharmaceutical Ingredient
DDI = Division of Drug Information
DMF = Drug Master File
eCTD = electronic Common Technical Document
GDUFA = Generic Drug User Fee Amendments
OBI = Office of Business Informatics
OC = Office of Compliance
OCOMM = Office of Communications
OGD = Office of Generic Drugs
OGD/DLPS = Office of Generic Drugs/Division of Labeling and Program
OM = Office of Management
OMPQ = Office of Manufacturing and Product Quality
ONDQA = Office of New Drug Quality Assessment
Day 2 - Friday March 28, 2014 
GDUFA Exploring Aspects
7:30a Registration Opens
8:15 - 8:25a Welcome
Renu Lal, Pharm.D
  Consumer Safety Officer
  Division of Drug Information (DDI)
  Office of Communications (OCOMM), CDER, FDA
8:25 - 8:40a Keynote Speaker
Kathleen M. Sinninger
  Director, Investigations Branch
  Florida District Office
8:40 - 9:40a GDUFA Implementation Policy Updates (remote)  Abstract
Keith Flanagan, J.D.
  Office of Generic Drugs (OGD) Transition Lead for Policy
  OGD, CDER, FDA
9:40 - 10:40a GDUFA Regulatory Science (remote)  Abstract
Robert A. Lionberger Ph.D.
  Acting Deputy Director for Science Office of Generic Drugs (OGD), CDER, FDA
10:40 - 10:50a BREAK
10:50 - 12:00p
User Fees / Arrears List/Appeals/Waivers Abstract
Donal Parks, M.B.A., M.P.M.
  Director
  Division of User Fee Management and Budget Formulation
  Office of Management (OM), CDER, FDA
12:00 - 1:15p LUNCH ON YOUR OWN-Networking opportunity
1:15 - 2:15p Post-Approval & Surveillance Inspection programs for Pharmaceutical Manufacturers Abstract
Alicia M. Mozzachio, R.Ph., MPH
  Branch Chief
  International Compliance Branch 1 (ICB1)
  Division of International Drug Quality (DIDQ)
  Office of Manufacturing and Drug Quality (OMPQ)
  CDER, Office of Compliance
2:15 - 2:25p BREAK
2:25 - 3:30p
Communications between FDA and Industry Abstract

GDUFA Review Efficiency Enhancements Abstract
Linda Park, Pharm.D., M.S.
  Regulatory Project Manager
  Office of Generic Drugs (OGD), CDER, FDA
3:30p ADJOURNMENT