Bioequivalence and Bioavailability Forum • Guidance vs. Guideline

Guidance vs. Guideline [BE/BA News]

posted by Ohlbe – France, 2013-08-20 11:51 (4692 d 08:08 ago) – Posting: # 11312
Views: 10,062

Dear Helmut and ElMaestro,

❝ So the EMEA decided to abandon PtC's and NfG's altogether.

My understanding was that "guideline" was preferred to "Note for guidance" because it is the wording used in Annex I to Directive 2001/83/EC. Nothing more.

—
Regards
Ohlbe

Complete thread:

EMA: Concept paper on product-specific BE guidances Helmut 2013-08-06 13:51
- If required?? ElMaestro 2013-08-06 14:02
  - Guidance vs. Guideline Helmut 2013-08-06 14:18
    - Guidance vs. Guideline ElMaestro 2013-08-06 16:27
      - Guidance vs. GuidelineOhlbe 2013-08-20 09:51
        
        Guidance vs. Guideline ElMaestro 2013-08-20 12:54