Bioequivalence and Bioavailability Forum • FDA

FDA - Biowaiver Class III [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2015-05-12 14:27 (4064 d 05:13 ago) – Posting: # 14791
Views: 5,239

Hi nobody,

❝ Is this new?

Yep. Samaya notified us last week.

The FDA proudly announced the revision at the “Global Bioequivalence Harmonisation Initiative” (March 2015, Amsterdam). Harmonized with their own product-specific recommendations and to a good part with EMA’s. Doubtful whether Japan will ever board the ship.

❝ ...class III biowaivers for FDA---

ƒ 90% ⇒ 85%
pH 7.5 ⇒ 6.8
Fixed Dose Combinations

If you want to explore further differences: The August 2000 guidance here.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

FDA - Biowaiver Class III nobody 2015-05-12 10:01
- FDA - Biowaiver Class IIIHelmut 2015-05-12 12:27
  - FDA - Biowaiver Class III nobody 2015-05-12 13:14
  - FDA - Biowaiver Class III jag009 2015-05-14 16:31
    - FDA - Biowaiver Class III Helmut 2015-05-14 18:51
- OT: Reality vs Guidance luvblooms 2015-05-15 07:31
  - OT: Reality vs Guidance nobody 2015-05-15 10:34
    - OT: Reality vs Guidance luvblooms 2015-05-15 12:09
      - OT: Reality vs Guidance nobody 2015-05-15 16:40