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Fda Submissions

4:34

What is an FDA pre-submission?

Medical Device Academy

686 views

1:31

What Are The 3 Types of FDA Pre-Market Submissions? By Proxima CRO

Proxima Clinical Research

1K views

29:56

FDA Pre-Submissions with Larry Stevens

leanRAQA

268 views

2:16

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

MedTech Crossroads

892 views

59:28

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

Nelson Labs

1.5K views

12:30

An Overview of FDA's Patent Listing Process

U.S. Food and Drug Administration

1.2K views

20:18

eCTD Submissions of Promotional Labeling and Advertising Materials

U.S. Food and Drug Administration

1.6K views

24:47

Crash Course in FDA Submissions

leanRAQA

914 views

18:22

Electronic Submissions (7of27) Generic Drugs Forum 2018

U.S. Food and Drug Administration

1.2K views

39:41

Referencing Approved Drug Products in ANDA Submissions

U.S. Food and Drug Administration

8.1K views

2:45

Changes to the FDA eCopy Submission Process

Medical Device Academy

489 views

29:14

Global Pathways Summit: FDA Submission Strategies

leanRAQA

225 views

5:15

Expanded Access Part 4: How to Complete Form FDA 3926 for Follow-Up Submissions

U.S. Food and Drug Administration

2.6K views

23:35

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

U.S. Food and Drug Administration

1.4K views

11:06

How to Prepare a Medical Device 510k Submission for FDA

Matrix Requirements

1.3K views

1:24

The Q-Submission Program | Proxima CRO

Proxima Clinical Research

393 views

36:23

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

U.S. Food and Drug Administration

2.5K views

57:18

Promotional Submissions in eCTD Format - Grouped Submissions

U.S. Food and Drug Administration

3K views

13:14

How long does it take FDA to review De Novo submissions?

Medical Device Academy

584 views

24:18

Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead!

U.S. Food and Drug Administration

3K views