Bioequivalence and Bioavailability Forum • John, are you there?

John, are you there? [Tips / Tricks]

posted by jag009 – NJ, 2013-05-28 23:12 (3979 d 01:18 ago) – Posting: # 10678
Views: 14,152

Hi Helmut!

We in US had Monday as a holiday you know. Yeah it's Tuesday and I am still on holiday mood... :party:

I "think" guidance is not cast in stone and you can present alternatives to FDA as long as you can justify them, even if it's the finalized guidance.

Guideline is cast in stone.

There are guidelines on FDA website. Example, Drug Master File Guideline

Regarding draft BA/BE guidances... Pretty much all the people I know treat the draft as final. In fact if you look at FDA's BE recommendations for specific drug products (The document which indicate the types of BE studies to be conducted), I think majority of them (I looked at some as far back as 2008) are still in draft.

Thanks
John

Complete thread:

Differences Irukulla Shravan Kumar 2013-05-28 06:00
- Hard and soft law Helmut 2013-05-28 14:22
- Differences ElMaestro 2013-05-28 14:37
  - John, are you there? Helmut 2013-05-28 14:56
    - John, are you there?jag009 2013-05-28 21:12
      - Guideline # guidance Helmut 2013-05-28 23:27
        
        Guideline # guidance jag009 2013-05-30 16:08
        
        As time passes by Helmut 2013-05-30 17:59
        
        As time passes by jag009 2013-05-31 15:15