FDA submission

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What is an FDA pre-submission?

0:59:28

Understanding the Power of the FDA Pre-Sub: Tips for a Successful Meeting

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

0:41:30

Meetings: Pre-submission and Special Programs (4of15) REdI Annual Conference – May 29-30, 2019

0:18:22

Electronic Submissions (7of27) Generic Drugs Forum 2018

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Breaking Down the FDA Pre-Submission Process - An Essential Guide

0:02:19

Understanding the FDA Medical Device 510k Process

0:02:41

What do FDA reviewers look for in 510 (k) and IDE submissions?

0:14:46

U S FDA Medical Device Pre Market Regulatory Submissions

0:16:44

Generic Labeling: Strategies for Providing High-quality Submissions (18/28) Generic Drugs Forum 2017

0:03:17

How does the FDA approve new drugs?

0:47:37

Electronic Submission of Safety Reports - Ready for Primetime

0:33:18

Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018

0:24:47

Crash Course in FDA Submissions

0:17:02

CDER BIMO: Electronic Submission Requirements for New Drug and Biologic Licensing Applications

0:23:35

Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence

0:36:55

Components of New Drug Application and Biologics License Application (5of15) REdI– May 29-30, 2019

0:59:21

Electronic Submission of Adverse Event Reports to FAERS using ICH E2B(R3) Standards - Oct. 11, 2019

0:36:23

Ready to Launch: Essentials of Submitting Initial Materials to OPDP (12of15) REdI– May 29-30, 2019

0:12:30

An Overview of FDA's Patent Listing Process

0:11:06

How to Prepare a Medical Device 510k Submission for FDA

0:35:52

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

0:02:32

What were the most common submission mistakes you saw as an FDA lead reviewer?

0:01:13

What criteria does the US FDA use to approve an IDE submission?