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© 2019 by Graematter

Pharma Today

Get Updates!

Collected and updated throughout the day to keep you informed.  Come back often!

CDER Guidance Documents

July - September 30, 2019

New

2019 YTD

Withdrawn

2019 YTD

Medication Guides

September 14 - October 14, 2019

New 2019 YTD

New 2018

NDAs, ANDAs & BLAs- New Originals & Supplements

Original NDA

2019 YTD

Original ANDA

2019 YTD

Original BLA

2019 YTD

September 24 - October 23, 2019

Drug Safety-Related Label Changes

Label Changes

2019 YTD

August - October 8, 2019

UNDER CONSTRUCTION

Thanks for stopping by!  We are still working here! 

Here are some possibles already proposed:

- Determination of Regulatory Review Period for Purposes of Patent Extension

- Product-Specific Guidance

- Pediatric Exclusivity 

- Postmarket Studies

- REMS

- Withdrawn Drugs

- Off-patent drug

- Accelerated Reviews

- FDA Meetings Schedule

- Advisory Committee Meetings and Results

- Drug Safety Communications

Give us suggestions for what you would want to see.  Add some comments below.