Pharma Today

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Guidance
NDAs & ANDAs
TBD
Labeling Changes
TBD
Accelerated Reviews

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

CDER Guidance Documents

New

2020 YTD

Withdrawn

2020 YTD

Medication Guides

New 2018

New 2019

New 2020 YTD

NDAs, ANDAs & BLAs- New Originals & Supplements

Original NDA

2019 YTD

Original ANDA

2019 YTD

Original BLA

2019 YTD

Drug Safety-Related Label Changes

Label Changes

2019

Label Changes

2020 YTD

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- Withdrawn Drugs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.