Pre-ANDA Program

(26:1econd)

Pre-ANDA Program Update and Tips for Success – OPQ Perspective

(19:54)

Pre-ANDA Meeting or Controlled Correspondence? (4of28) Generic Drugs Forum – Apr. 3-4, 2019

(19:49)

GDUFA II Training - Pre ANDA Product Development Meetings, Robert Lionberger

(5:37)

Pre-ANDA Interactions with the FDA (6of16) Generic Drugs Forum 2020

(35:52)

Pre-ANDA review: Office of Pharmaceutical Quality (OPQ) (4of39) Complex Generics 2018

(17:27)

Pre-ANDA Program Overview (2of39) Complex Generics 2018

(20:56)

Pre-ANDA Program Update (2of35) Complex Generics– Sep. 25-26, 2019

(30:23)

Pre-ANDA Logistics and Best Practices (3of39) Complex Generics 2018

(46:47)

GDUFA II Training - Pre ANDA Program Pre Submission Meetings, Robert Lionberger

(4:50)

GDUFA II Pre-ANDA Program Meetings: Advice for Success (10of27) Generic Drugs Forum 2018

(23:6)

Pre-ANDA Meeting Requests for Orally Inhaled/Nasal Drugs(24of35) Complex Generics – Sep. 25-26, 2019

(15:5)

Using the ePortal to Submit a pre-ANDA Meeting (8of27) Generic Drugs Forum 2018

(10:15)

Pre-ANDA Logistics and Best Practices (27of39) Complex Generics 2018

(31:18)

ANDA Program Performance Review and Tips (8of16) Generic Drugs Forum 2020

(38:23)

Peptide Drug Challenges through Pre-ANDA Processes \u0026 Case Studies (6of39) Complex Generics 2018

(18:5)

Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval

(2:26:13)

Pre-ANDA Meeting or Controlled Correspondence- FDA Generic Drug Forum 2019

(19:35)

D2,S7,S1-Pre-ANDA Evaluation of Drug Delivery Device Constituent

(14:41)

ANDAs: Pre-Submission Facility Correspondence (PFC) Related to Prioritized Generic Drug Submissions

(8:8)