Bioequivalence and Bioavailability Forum • End of consultation approaching‼

End of consultation approaching‼ [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-03-01 21:09 (4498 d 11:47 ago) – Posting: # 12541
Views: 14,420

Hi Osama,

❝ why you don't send your above comments? :confused:

❝ Are the comments allowed and accepted only from companies?

No. There is a drop-down box where you can select whether you submit comments on behalf of government, international government, academia, industry and many others. If your post you private opinion, you can even chose to state in the name-field “Anonymous” if you don’t want your comments published. But: After submitting you get a ticket № for further reference and the comment will be made public after review by the FDA. Obviously they want to avoid “FDA is stuuupid” comments by script-kiddies to automatically going public.

❝ I find your comments are reasonable and rational.

THX.

In the meantime five comments have been submitted and only three are shown. We find on the page:
This count refers to the total comments received on this docket, as of 11:59 PM yesterday, from Regulations.gov and alternate means. All comments including the bulk submissions received for this docket may not be posted at this time; therefore, the counts may differ between: total comments received and posted, as well as the counts shown on the Docket Folder Summary page.

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Helmut Schütz

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Science Quotes

Complete thread:

Draft FDA Guidance Dec 2013 pash413 2013-12-04 15:05
- First impressions Helmut 2013-12-04 16:47
  - First impressions nasir 2014-02-14 06:47
- What is Bioequivalence in the US really? ElMaestro 2013-12-07 23:34
  - Site of action vs. systemic circulation Helmut 2013-12-08 02:05
- Draft FDA Guidance Dec 2013 drgunasakaran1 2013-12-08 08:39
  - Two-stage or RSABE Helmut 2013-12-08 13:59
    - Two-stage or RSABE ElMaestro 2013-12-08 14:17
      - Two-stage methods Helmut 2013-12-08 14:44
        
        Two-stage methods ElMaestro 2013-12-08 18:56
    - RSABE Lucas 2014-03-24 17:05
      - RSABE Helmut 2014-03-24 17:25
        
        RSABE Lucas 2014-03-25 13:33
        
        RSABE Helmut 2014-03-25 14:31
        
        RSABE Lucas 2014-03-26 15:19
        
        RSABE Helmut 2014-03-26 15:28
  - Draft FDA Guidance Dec 2013 jag009 2013-12-09 22:31
    - Draft FDA Guidance Dec 2013 kvgreddy06 2014-02-14 16:44
- End of consultation approaching‼ Helmut 2014-02-26 11:32
  - End of consultation approaching‼ wien-ui 2014-03-01 08:05
    - End of consultation approaching‼Helmut 2014-03-01 20:09
      - End of consultation approaching‼ wien-ui 2014-03-04 10:53